Ligament fixation system, implants, devices, and methods of use

ABSTRACT

Devices, systems, implants and methods for achieving ligament fixation are disclosed. An implant includes a head member and an anchor member coupled to the head member. The implant includes tension member that couples the head member to the anchor member. The head member and the anchor member include a cannulation that receives the tension member therein. The implant may include a coupling member positioned between and coupling the head member and the anchor member, the coupling member including a cannulation that receives the tension member therethrough. Insertion instruments for inserting an implant for ligament fixation are also disclosed. Methods of using an implant for achieving ligament fixation are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of PCT international patentapplication No. PCT/US2018/055028, filed Oct. 9, 2018, entitled LigamentFixation System, Implants, Devices, and Methods of Use, which claimspriority benefit of U.S. provisional application No. 62/569,238, filedOct. 6, 2017, entitled Ligament Fixation System, Implants, Devices, andMethods of Use, which are hereby incorporated herein by reference intheir entireties.

TECHNICAL FIELD

The present disclosure relates generally to general, podiatric, andorthopaedic surgery related to fixation of ligaments. More specifically,but not exclusively, the present disclosure relates to devices, systems,and methods for achieving dynamic ligament fixation.

BACKGROUND

Syndesmotic injuries are a result of trauma (not specific to sportsinjuries) and can occur as a purely ligamentous injury or in combinationwith an ankle fracture. These ligaments become disrupted, separated, orinjured where semi-constrained approximation and fixation is needed toaide in healing without the need for a second surgery such as removal ofa rigid fixation screw. The current standard of care for syndesmoticinjuries involves either rigid fixation with a screw, or a tether-basedconstraint across the entire width of the ankle (TightRope, etc.).

The more rigid screw-based fixation is simple to implant and stabilizesthe joint, but fails to allow any motion at all, as would normally existphysiologically. This limits the patient's range of motion, andunpredictable screw failure locations can result in damage to existingbone and patient pain.

Tethered constraints, such as the Arthrex Tightrope, do allow for motionof the joint, but by spanning the entire width of the ankle, fail tomimic the intact ligament structures of the syndesmosis in terms ofattachment location and distance between the tibia and fibula. However,tethered constraints result in a necessary decrease in structuralstrength due to the surgical technique of the Tightrope and like devicesinvolving drilling a hole through both the tibia and fibula whichremains unfilled by structural material (e.g. a metal screw).

Thus, new and improved devices, systems, and methods for achievingligament fixation are needed to overcome the above-noted drawbacks ofthe currently available solutions for addressing syndesmotic injuries.

SUMMARY

The present disclosure is directed toward devices and methods for use inligament fixation. The devices, systems, and methods for achievingligament fixation.

In one aspect of the present disclosure provided herein, is an implant.The implant including a head member and an anchor member coupled to thehead member.

In another aspect of the present disclosure provided herein, is aninsertion instrument. The insertion instrument, including a first shaft,a second shaft extending away from the first shaft, a first featurepositioned at a first end of the second shaft; and a second featurepositioned at the second end of the second shaft.

In yet another aspect of the present disclosure provided herein, is asystem. The system including an implant with a head member and an anchormember coupled to the head member and an insertion instrument forcoupling to the implant.

In a further aspect of the present disclosure provided herein, is amethod for inserting an implant. The method including obtaining theimplant. The implant including a head member and an anchor membercoupled to the head member. The method also including engaging theimplant with an insertion instrument and inserting the implant into apatient to position the head member in a first bone and the anchormember in a second bone.

In a further aspect of the present disclosure an implant is disclosed.The implant comprises a head member, an anchor member, and a tensionmember coupling the head member to the anchor member. The head memberand the anchor member include a cannulation that receives the tensionmember therein.

In some embodiments, the head member directly engages the anchor member.In some embodiments, the implant further comprises a coupling memberpositioned between and coupling the head member and the anchor member.In some embodiments, the coupling member includes a cannulation thatreceives the tension member therethrough. In some embodiments, the headmember comprises a first engagement protrusion, the anchor membercomprises a second engagement protrusion, and the coupling membercomprises a first engagement aperture that receives the first engagementprotrusion of the head member and a second engagement aperture thatreceives the second engagement protrusion of the anchor member. In someembodiments, the first engagement protrusion, the second engagementprotrusion, the first engagement aperture and the first engagementaperture define a non-circular cross-section. In some embodiments, thefirst engagement protrusion, the second engagement protrusion, the firstengagement aperture and the first engagement aperture define anon-circular cross-section that includes a plurality of lobes with arecess extending between adjacent lobes.

In some embodiments, the cannulation of the head member extends throughthe first engagement protrusion, the cannulation of the anchor memberextends through the second engagement protrusion, and the cannulation ofthe head member is in communication with the first and second engagementapertures. In some embodiments, the head member comprises a head portionand a shaft portion extending from the head portion, the head portiondefining a free end of the implant. In some embodiments, the headportion includes a non-circular drive aperture and the shaft portionincludes external threads. In some embodiments, the drive aperture is incommunication with the cannulation of the head member.

In some embodiments, the cannulation of the head member includes a firstenlarged portion positioned proximate to the head portion and a secondnarrow portion positioned distal to the head portion and proximate tothe anchor member. In some embodiments, the implant further comprises ahead post member positioned within the first enlarged portion of thecannulation of the head member, and the head post member is coupled to afirst portion of the tension member. In some embodiments, the head postmember comprises a cannulation, and the tension member extends at leastpartially through the cannulation of the head post member. In someembodiments, the head post member is coupled to the first portion of thetension member via at least one pin extending at least partially throughthe head post member and the tension member.

In some embodiments, the head post member is externally threaded, thecannulation of the head post member comprises an internally-threadedportion, and the head post member and the internally-threaded portionare threadably engaged. In some such embodiments, the first enlargedportion comprises the internally-threaded portion.

In some embodiments, the implant farther comprises at least one elasticmember positioned within the first enlarged portion of the cannulationof the head member between the head post member and the second narrowportion of the cannulation of the head member. In some embodiments, theat least one elastic member comprises at least one disc spring, coilspring or elastic tube. In some embodiments, the at least one elasticmember comprises a plurality of disc springs. In some embodiments, theplurality of disc springs include a plurality of adjacent disc springsoriented in the same axial direction and a plurality of adjacent discsprings oriented in opposing axial directions. In some embodiments, theplurality of adjacent disc springs oriented in opposing axial directionsare elastically deformed and provide an assembly tension to the tensionmember that maintains head member and anchor member in engagement. Insome embodiments, the plurality of adjacent disc springs oriented in thesame axial direction and are elastically deformed after implantation ofthe implant to dissipate diastatic motion and/or pressure spikes. Insome embodiments, the at least one elastic member is embedded in abioresorbable material.

In some embodiments, the at least one elastic member comprises anelastic bumper member. In some such embodiments, the elastic bumpermember defines a tube, and the tension member passes through an apertureof the tube. In some embodiments, the elastic bumper member is formed ofthermoplastic urethane, polycarbonate urethane or a combination thereof.

In some embodiments, the anchor member comprises an externally threadedportion and a non-threaded crimp portion, the non-threaded crimp portiondefining a free end of the implant. In some embodiments, the implantfurther comprises a tip post member positioned within the cannulation ofthe anchor member, the tip post member coupled to a second portion ofthe tension member. In some embodiments, the tip post member comprises acannulation, and the tension member extends at least partially throughthe cannulation of the tip post member. In some embodiments, the tippost member is coupled to the second portion of the tension member viaat least one pin extending at least partially through the tip postmember and the tension member. In some embodiments, the tip post membercomprises a hook slot extending from an end of the tip post memberpositioned proximate to the free end of the implant defined by the crimpportion. In some embodiments, the tip post member comprises a recess inan outer surface thereof, the recess configured to accept a deformedportion of the crimp portion of the anchor member therein to axially fixthe tip post within the cannulation of the anchor member.

In some embodiments, the tension member is a suture. In someembodiments, the suture includes a loop. In some embodiments, the sutureis a bifurcated suture that forms a loop portion positioned betweenfirst and second non-bifurcated end portions. In some embodiments, thefirst non-bifurcated end portion of the suture is coupled to the headmember and the second non-bifurcated end portion of the suture iscoupled to the anchor member. In some embodiments, the tension member ismade of a bioresorbable material. In some embodiments, the implantfurther comprises a coupling positioned between the head member and theanchor member, the tension member engaging channels in the spacer. Insome embodiments, the coupling is made of a bioresorbable material.

In a further aspect of the present disclosure, a method of inserting animplant is provided. The method comprises obtaining an implant, theimplant comprises an implant provided herein. The method also comprisesengaging the implant with an insertion instrument, and inserting theimplant into a patient to position the head member in a first bone andthe anchor member in a second bone.

In some embodiments, the first bone is a fibula and the second bone is atibia. In some embodiments, the implant is inserted as a one-piececonstruct. In some embodiments, the implant allows for motion betweenthe first bone and the second bone.

In a further aspect of the present disclosure, an insertion instrumentis provided. The instrument comprises a first shaft, a second shaftextending away from the first shaft, a first feature positioned at afirst end of the second shaft, and a second feature positioned at thesecond end of the second shaft.

In a further aspect of the present disclosure, a system is provided. Thesystem comprises an implant comprising an implant and an insertioninstrument for coupling to the implant, the implant comprises an implantprovided herein.

These and other objects, features and advantages of this disclosure willbecome apparent from the following detailed description of the variousaspects of the disclosure taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the detailed description herein, serve to explain theprinciples of the disclosure. It is emphasized that, in accordance withthe standard practice in the industry, various features are not drawn toscale. In fact, the dimensions of the various features may bearbitrarily increased or reduced for clarity of discussion. The drawingsare only for purposes of illustrating preferred embodiments and are notto be construed as limiting the disclosure.

FIG. 1 is a side perspective view of one embodiment of an implant, inaccordance with an aspect of the present disclosure;

FIG. 2 is a side view of the implant of FIG. 1, in accordance with anaspect of the present disclosure;

FIG. 3 is a first cross-sectional view of the implant of FIG. 1 takenalong line 3-3 in FIG. 2, in accordance with an aspect of the presentdisclosure;

FIG. 4 is a second cross-sectional view of the implant of FIG. 1 takenalong a longitudinal line perpendicular to line 3-3 in FIG. 2, inaccordance with an aspect of the present disclosure;

FIG. 5 is a perspective view of the implant of FIG. 1 after thebioresorbable drive coupling of the implant is absorbed, in accordancewith an aspect of the present disclosure;

FIG. 6 is an exploded side view of the head member, the anchor member,and the drive coupling of the implant of FIG. 1, in accordance with anaspect of the present disclosure;

FIG. 7 is a distal, transverse planar view of a fibula and tibia with ak-wire inserted through a plate, the fibula and into the tibia, inaccordance with an aspect of the present disclosure;

FIG. 8 is a distal, transverse planar view of the bones of FIG. 7 with adrill inserted over the k-wire of FIG. 7 through the plate, fibula andinto the tibia, in accordance with an aspect of the present disclosure;

FIG. 9 is a distal, transverse planar view of the bones of FIG. 7 afterthe drill and k-wire are removed, in accordance with an aspect of thepresent disclosure;

FIG. 10 is a distal, transverse planar view of the bones of FIG. 7 withthe implant of FIG. 1 inserted into the drilled opening with a driverinstrument, in accordance with an aspect of the present disclosure;

FIG. 11 is a posterior view of the bones of FIG. 7 with the implant ofFIG. 1 inserted through the plate, fibula and into the tibia, inaccordance with an aspect of the present disclosure;

FIG. 12 is a perspective side view of yet another implant, in accordancewith an aspect of the present disclosure;

FIG. 13 is a side view of the implant of FIG. 12, in accordance with anaspect of the present disclosure;

FIG. 14 is a first cross-sectional view of the implant of FIG. 12 takenalong line 14-14 in FIG. 13, in accordance with an aspect of the presentdisclosure;

FIG. 15 is a second cross-sectional view of the implant of FIG. 12 takenalong a longitudinal line perpendicular to line 14-14 in FIG. 13, inaccordance with an aspect of the present disclosure;

FIG. 16 is a distal, transverse planar view of the bones of FIG. 7 withthe implant of FIG. 12 inserted into the drilled opening with a driverinstrument, in accordance with an aspect of the present disclosure;

FIG. 17 is a perspective side view of another implant, in accordancewith an aspect of the present disclosure;

FIG. 18 is a side view of the implant of FIG. 17, in accordance with anaspect of the present disclosure;

FIG. 19 is a first cross-sectional view of the implant of FIG. 17 takenalong line 19-19 in FIG. 18, in accordance with an aspect of the presentdisclosure;

FIG. 20 is a second cross-sectional view of the implant of FIG. 17 takenalong a longitudinal line perpendicular to line 19-19 in FIG. 18, inaccordance with an aspect of the present disclosure;

FIG. 21 is a distal, transverse planar view of the bones of FIG. 7 withthe implant of FIG. 17 inserted into the drilled opening with a driverinstrument, in accordance with an aspect of the present disclosure;

FIG. 22 is a distal, transverse planar view of the bones of FIG. 7 afterthe driver instrument is removed from the implant of FIG. 17 and theremaining disengagement suture is pulled to release the direct drivecoupling, in accordance with an aspect of the present disclosure;

FIG. 23 is a distal, transverse planar view of the bones of FIG. 7 aftercutting the disengagement suture of FIG. 22, in accordance with anaspect of the present disclosure;

FIG. 24 is a first end, perspective view of another implant, inaccordance with an aspect of the present disclosure;

FIG. 25 is a second end, perspective view of the implant of FIG. 24, inaccordance with an aspect of the present disclosure;

FIG. 26 is a side view of the implant of FIG. 24, in accordance with anaspect of the present disclosure;

FIG. 27 is a first cross-sectional view of the implant of FIG. 25 takenalong line 27-27 in FIG. 26, in accordance with an aspect of the presentdisclosure;

FIG. 28 is a second cross-sectional view of the implant of FIG. 25 takenalong a longitudinal line perpendicular to line 27-27 in FIG. 26, inaccordance with an aspect of the present disclosure;

FIG. 29 is a partially exploded, first end perspective view of theimplant of FIG. 25, in accordance with an aspect of the presentdisclosure;

FIG. 30 is a partially exploded, second end perspective view of theimplant of FIG. 25, in accordance with an aspect of the presentdisclosure;

FIG. 31 is an exploded, first end perspective view of the implant ofFIG. 25, in accordance with an aspect of the present disclosure;

FIG. 32 is an exploded, second end perspective view of the implant ofFIG. 25, in accordance with an aspect of the present disclosure;

FIG. 33 is a perspective view of a portion of an insertion instrumentfor inserting the implant of FIG. 25, in accordance with an aspect ofthe present disclosure;

FIG. 34 is an enlarged, perspective view of an end of the insertioninstrument of FIG. 33, in accordance with an aspect of the presentdisclosure;

FIG. 35 is a distal, transverse planar view of the bones of FIG. 7 withthe implant of FIG. 24 inserted into the drilled opening with a driverinstrument, in accordance with an aspect of the present disclosure;

FIG. 36 is a posterior view of the bones of FIG. 35 with the implant ofFIG. 24 inserted through the fibula and into the tibia, in accordancewith an aspect of the present disclosure;

FIG. 37 is a perspective view of yet another implant, in accordance withan aspect of the present disclosure;

FIG. 38 is a side view of the implant of FIG. 37, in accordance with anaspect of the present disclosure;

FIG. 39 is a first cross-sectional view of the implant of FIG. 37 takenalong line 39-39 in FIG. 38, in accordance with an aspect of the presentdisclosure;

FIG. 40 is a second cross-sectional view of the implant of FIG. 37 takenalong a longitudinal line perpendicular to line 39-39 in FIG. 38, inaccordance with an aspect of the present disclosure;

FIG. 41 is a partially exploded, first end perspective view of theimplant of FIG. 37, in accordance with an aspect of the presentdisclosure;

FIG. 42 is a partially exploded, second end perspective view of theimplant of FIG. 37, in accordance with an aspect of the presentdisclosure;

FIG. 43 is an exploded, first end perspective view of the implant ofFIG. 37, in accordance with an aspect of the present disclosure;

FIG. 44 is a distal, transverse planar view of the bones of FIG. 7 withthe implant of FIG. 37 inserted into the drilled opening with a driverinstrument, in accordance with an aspect of the present disclosure;

FIG. 45 is a posterior view of the bones of FIG. 44 with the implant ofFIG. 37 inserted through the fibula and into the tibia, in accordancewith an aspect of the present disclosure;

FIG. 46 is a perspective view of another implant, in accordance with anaspect of the present disclosure;

FIG. 47 is a side view of the implant of FIG. 46, in accordance with anaspect of the present disclosure;

FIG. 48 is a first cross-sectional view of the implant of FIG. 46 takenalong line 48-48 in FIG. 47, in accordance with an aspect of the presentdisclosure;

FIG. 49 is a second cross-sectional view of the implant of FIG. 46 takenalong a longitudinal line perpendicular to line 48-48 in FIG. 47, inaccordance with an aspect of the present disclosure;

FIG. 50 is an exploded, first end perspective view of the implant ofFIG. 46, in accordance with an aspect of the present disclosure;

FIG. 51 is an exploded, second end perspective view of the implant ofFIG. 46, in accordance with an aspect of the present disclosure;

FIG. 52 is a distal, transverse planar view of the bones of FIG. 7 withthe implant of FIG. 46 inserted into the drilled opening with a driverinstrument, in accordance with an aspect of the present disclosure;

FIG. 53 is a side view of an alternative middle portion of the implantsof FIGS. 24, 37, and 46, in accordance with an aspect of the presentdisclosure;

FIG. 54 is a side view of another alternative middle portion of theimplants of FIGS. 24 and 37 in a contracted position, in accordance withan aspect of the present disclosure;

FIG. 55 is a side view of the middle portion of FIG. 54 in an extendedposition, in accordance with an aspect of the present disclosure;

FIG. 56 is a perspective view of another implant, in accordance with anaspect of the present disclosure;

FIG. 57 is a first side view of the implant of FIG. 56, in accordancewith an aspect of the present disclosure;

FIG. 58 is a second side view of the implant of FIG. 56, in accordancewith an aspect of the present disclosure;

FIG. 59 is a perspective, cross-sectional view of the implant of FIG. 56taken along line 59-59 in FIG. 57, in accordance with an aspect of thepresent disclosure;

FIG. 60 is a side, cross-sectional view of the implant of FIG. 56 takenalong line 59-59 in FIG. 57, in accordance with an aspect of the presentdisclosure;

FIG. 61 is a perspective view of a portion of the implant of FIG. 60, inaccordance with an aspect of the present disclosure.

FIG. 62 is a perspective side view of another implant, in accordancewith an aspect of the present disclosure;

FIG. 63 is another perspective side view of the implant of FIG. 62, inaccordance with an aspect of the present disclosure;

FIG. 64 is another perspective side view of the implant of FIG. 62, inaccordance with an aspect of the present disclosure;

FIG. 65 is another perspective side view of the implant of FIG. 62, inaccordance with an aspect of the present disclosure;

FIG. 66 is a side view of the implant of FIG. 62, in accordance with anaspect of the present disclosure;

FIG. 67 is another side view of the implant of FIG. 62, in accordancewith an aspect of the present disclosure;

FIG. 68 is an exploded perspective side view of the implant of FIG. 62,in accordance with an aspect of the present disclosure;

FIG. 69 is another exploded perspective side view of the implant of FIG.62, in accordance with an aspect of the present disclosure;

FIG. 70 is an exploded side view of the implant of FIG. 62, inaccordance with an aspect of the present disclosure;

FIG. 71 is another exploded side view of the implant of FIG. 62, inaccordance with an aspect of the present disclosure;

FIG. 72 is an exploded perspective side view of the implant of FIG. 62illustrating a tension member, resilient member, head pin, coupling,head member and head post of the implant, in accordance with an aspectof the present disclosure;

FIG. 73 is another exploded perspective side view of the implant of FIG.62 illustrating the tension member, resilient member, head pin,coupling, head member and head post of the implant, in accordance withan aspect of the present disclosure;

FIG. 74 is an exploded perspective side view of the implant of FIG. 62illustrating a tension member, tip pin, anchor member and tip post ofthe implant, in accordance with an aspect of the present disclosure;

FIG. 75 is another exploded perspective side view of the implant of FIG.62 illustrating the tension member, tip pin, anchor member and tip postof the implant, in accordance with an aspect of the present disclosure;

FIG. 76 is a side perspective view of the implant of FIG. 62illustrating the engagement of the tension member, anchor member andhead member of the implant, in accordance with an aspect of the presentdisclosure;

FIG. 77 is another side perspective view of the implant of FIG. 62illustrating the engagement of the tension member, anchor member andhead member of the implant, in accordance with an aspect of the presentdisclosure;

FIG. 78 is a side cross-sectional view of a portion of the implant ofFIG. 62 illustrating the engagement of the tip post and the tensionmember in the cannulation of the anchor member, in accordance with anaspect of the present disclosure;

FIG. 79 is another side perspective view of the tip post and the tip pinof the implant of FIG. 62 illustrating a partially-assembledconfiguration, in accordance with an aspect of the present disclosure;

FIG. 80 is a side perspective view of the tip post, tip pin and tensionmember of the implant of FIG. 62 illustrating an assembled configurationthereof, in accordance with an aspect of the present disclosure;

FIG. 81 is an enlarged perspective side view of the tip post, tip pinand tension member of the implant of FIG. 62 illustrating the assembledconfiguration thereof, in accordance with an aspect of the presentdisclosure;

FIG. 82 is a perspective side view of the implant of FIG. 62,illustrating the head member in an assembled configuration, inaccordance with an aspect of the present disclosure;

FIG. 83 is a perspective side view of the implant of FIG. 62,illustrating the anchor member in an assembled configuration, inaccordance with an aspect of the present disclosure;

FIG. 84 is another side cross-sectional view of a portion of the implantof FIG. 62 illustrating the engagement of the tip post and the tensionmember in the cannulation of the anchor member, in accordance with anaspect of the present disclosure;

FIG. 85 is an exploded perspective side view of the implant of FIG. 62,illustrating the head post, tension member, resilient member andcoupling in a partially-assembled configuration, in accordance with anaspect of the present disclosure;

FIG. 86 is another perspective side view of the implant of FIG. 62,illustrating the head member in an assembled configuration, inaccordance with an aspect of the present disclosure;

FIG. 87 is a side view of the implant of FIG. 62, illustrating thetension member, head post, resilient member and coupling in apartially-assembled configuration, in accordance with an aspect of thepresent disclosure;

FIG. 88 is a side cross-sectional view of a portion of another implant,in accordance with an aspect of the present disclosure;

FIG. 89 is a side cross-sectional perspective view of a portion of theimplant of FIG. 88, in accordance with an aspect of the presentdisclosure;

FIG. 90 is a side perspective view of a portion of the implant of FIG.88 illustrating an elastic member, a head post and a tension memberthereof in an exploded arrangement, in accordance with an aspect of thepresent disclosure;

FIG. 91 is a side cross-sectional perspective view of a portion of theimplant of FIG. 88 illustrating the elastic member, the head post andthe tension member thereof in an exploded arrangement, in accordancewith an aspect of the present disclosure;

FIG. 92 is a perspective side view of another head member for animplant, in accordance with an aspect of the present disclosure; and

FIG. 93 is a side cross-sectional perspective view of the head member ofFIG. 92, in accordance with an aspect of the present disclosure.

DETAILED DESCRIPTION

Generally stated, disclosed herein are devices and systems for achievingligament fixation. Further, methods for using the devices and systems toachieve ligament fixation are discussed.

In this detailed description and the following claims, the wordsproximal, distal, anterior or plantar, posterior or dorsal, medial,lateral, superior and inferior are defined by their standard usage forindicating a particular part or portion of a bone or implant accordingto the relative disposition of the natural bone or directional terms ofreference. For example, “proximal” means the portion of a device orimplant nearest the torso, while “distal” indicates the portion of thedevice or implant farthest from the torso. As for directional terms,“anterior” is a direction towards the front side of the body,“posterior” means a direction towards the back side of the body,“medial” means towards the midline of the body, “lateral” is a directiontowards the sides or away from the midline of the body, “superior” meansa direction above and “inferior” means a direction below another objector structure. Further, specifically in regards to the foot, the term“dorsal” refers to the top of the foot and the term “plantar” refers thebottom of the foot.

Similarly, positions or directions may be used herein with reference toanatomical structures or surfaces. For example, as the current implants,devices, instrumentation and methods are described herein with referenceto use with the bones of the ankle, the bones of the foot, ankle andlower leg may be used to describe the surfaces, positions, directions ororientations of the implants, devices, instrumentation and methods.Further, the implants, devices, instrumentation and methods, and theaspects, components, features and the like thereof, disclosed herein aredescribed with respect to one side of the body for brevity purposes.However, as the human body is relatively symmetrical or mirrored about aline of symmetry (midline), it is hereby expressly contemplated that theimplants, devices, instrumentation and methods, and the aspects,components, features and the like thereof, described and/or illustratedherein may be changed, varied, modified, reconfigured or otherwisealtered for use or association with another side of the body for a sameor similar purpose without departing from the spirit and scope of thedisclosure. For example, the implants, devices, instrumentation andmethods, and the aspects, components, features and the like thereof,described herein with respect to the right leg may be mirrored so thatthey likewise function with the left leg. Further, the implants,devices, instrumentation and methods, and the aspects, components,features and the like thereof, disclosed herein are described withrespect to the leg for brevity purposes, but it should be understoodthat the implants, devices, instrumentation and methods may be used withother bones of the body having similar structures.

Referring to the drawings, wherein like reference numerals are used toindicate like or analogous components throughout the several views, andwith particular reference to FIGS. 1-87, there is illustrated implants100, 300, 400, 500, 600, 700 and 900. The implants 100, 300, 400, 500,600, 700 and 900 may be, for example, supportive enough to healsyndesmotic ligaments post-operatively. The implants 100, 300, 400, 500,600, 700 and 900 may also, for example, selectively constrain motion inall directions to allow for the ligaments to heal. After the syndesmoticligaments heal, the implants 100, 300, 400, 500, 600, 700 and 900 allowfor physiologic motion. In addition, the implants 100, 300, 400, 500,600, 700 and 900 re-create pressure in the lateral gutter. Thecomponents of the implants 100, 300, 400, 500, 600, 700 and 900 may bemade of, for example, titanium, stainless steel, polymers, polyester orUHMWPE suture, resorbable suture, co-braids thereof, thermoplasticurethane bumper, and resorbable time release materials or polymers.

The implants 100, 300, 700 and 900 also allow for screw-likeimplantation and temporary rigid fixation, then, after insertion, theimplants 100, 300, 700 and 900 transition to semi-constrained motion.The implants 400, 500, 600 allow for screw-like implantation, and allowsemi-constrained motion without a period of rigid fixation. Thetemporary rigid fixation of the implants 100, 300, 700 and 900 gives thefixed joint time to stabilize through healing and then allowsphysiologic motion. The area of allowed motion in implants 100, 300,400, 500, 600, 700 and 900 is set in the space or gap between the fibulaand tibia, where the subsequent risk of damage to native bone is lower.The tension member or tether 150, 310, 410, 550, 640, 800, 850 mimicsthe interosseous ligament in both location and length. In addition, thecomponents in the tibia and fibula protect native bone from abrasionfrom the tension members 150, 310, 410, 550, 640, 800, 850, 950 and viceversa. The surgical method includes drilling a hole through both thetibia and fibula and then inserting an implant 100, 300, 400, 500, 600,700 or 900 sized to fill the bone holes or cavities to provide astronger post-op construct.

Referring now to FIGS. 1-11, the implant 100 is illustrated. The implant100 includes a head member or fibula member 110, an anchor member ortibia member 130, a tension member 150, and a coupling 160. The coupling160 may be positioned between the head member 110 and the anchor member130 and allow for the anchor member 130 to be secured into the bones180, 182 when the head member 110 is rotated. The tension member 150 mayextend through a center of at least a portion of the aligned head member110, the coupling 160, and at least a portion of the anchor member 130.The implant 100 may have a length of, for example, approximately 40 mmto 70 mm. In one embodiment, the lengths of the head member 110 and thecoupling 160 may remain constant, while the length of the anchor member130 may be variable to correspond to the varying size of a patient'sbones 180, 182. Alternatively, in another embodiment, the head member110 may, for example, be available in multiple lengths to correspond tothe varying sizes of patient bones 180, 182 and the lengths of theanchor member 130 and the coupling 160 may remain constant. In yetanother embodiment, both the head member 110 and the anchor member 130may be available in multiple lengths to allow for selection based on thesize of the patient's bones 180, 182 and the coupling 160 may remainconstant. Therefore, the head member 110 may have a length of, forexample, between approximately 10 mm and 20 mm, the anchor member 130may have a length of, for example, between approximately 20 mm and 60mm, and the coupling 160 may have a length of, for example,approximately 3 mm.

As shown in at least FIGS. 5 and 6, the head member 110 includes a shaftmember 116 with a head or button 112 at a first end and an engagementend or mating jaw 122 at the second end. The head 112 may include a toolengagement opening 114 positioned opposite the shaft member 116. Thetool engagement opening 114 may have, for example, a multi-lobed shapeas shown in FIG. 5, although other polygonal shapes are alsocontemplated, including a hexagonal shape or a hexalobular drivefeature. The shaft member 116 may include at least one transverseopening 118 and a through hole or cannulated opening 120. The cannulatedopening 120 may extend through the entire head member 110 along thelongitudinal axis of the head member 110. The at least one opening 118may extend perpendicular to the cannulated opening 120 and may extendfrom an exterior surface of the head member 110 at least into thecannulated opening 120.

The engagement end 122 may include at least one protrusion or tooth 124and at least one groove or recess 126, as shown in FIG. 6. For example,in the depicted embodiment, the engagement end 122 includes threeprotrusions 124 alternating with three recesses 126. The head member 110may also include an internal crimping feature 128, for example, a crimpferrule positioned within the through hole 120 near the head 112, asshown in FIGS. 3 and 4. The crimping feature 128 may secure a first end152 of the tension member 150 to the head member 110. Alternatively, thehead member 110 may include slots, windows, recesses, apertures (notshown) inset into the interior diameter of the opening 120 andpositioned opposite the openings 118. The slots (not shown) may be sizedand shaped to receive a pin or engagement member (not shown). The pin(not shown) may be inserted through the openings 118 to engage thetension member 150 and push a portion of the tension member 150 into theopposing slots (not shown) securing the tension member 150 to the headmember 110. The slots (not shown) may be, for example, slightly offsetfrom the openings 118 to provide additional securement of the tensionmember 150 to the head member 110. The pins (not shown) may also becoupled to the head member 110 by, for example, laser welding to preventa pin from disengaging the head member 110 after insertion into apatient. The head member 110 may be made of, for example, titanium,stainless steel, polymer, or another like material as would be known byone of ordinary skill in the art. Although not shown, the head member110 may, for example, also optionally be threaded on at least a portionof the exterior surface between the head 112 and the engagement end 122.

With continued reference to FIGS. 5 and 6, the anchor member 130 mayinclude a threaded shaft 132 with an engagement end or mating jaw 138 ata first end and at least one crimp member 144 at a second end. Thethreaded shaft 132 may be, for example, threaded along the entire lengthof the shaft or only along a portion of the shaft. The threaded shaft132 may also include a through hole or cannulated opening 134 extendingfrom the first end to the second end along the longitudinal axis of theanchor member 130. The threaded shaft 132 may also include at least onetransverse opening 136 extending from an exterior surface of thethreaded shaft 132 into the through hole 134. The engagement end ormating jaw 138 may include at least one protrusion or tooth 140 and atleast one groove or recess 142, as shown in FIG. 6. For example, in thedepicted embodiment, the engagement end 138 includes three protrusions140 alternating with three recesses 142. Although not shown, it is alsocontemplated that the second end of the anchor member 130 may include atleast one cutting element, for example, at least one cutting flute, suchas the cutting flutes on the insertion end 536, as shown in FIGS. 24-32.The at least one cutting element may be, for example, four cuttingflutes. It is also contemplated that the cutting flutes at the insertionend may be used as a removal feature if a medial approach is used toremove at least the anchor member 130.

The at least one crimp member 144 may be, for example, two crimp members144 spaced apart and surrounding the cannulated opening 134 of theanchor member 130, as shown in FIGS. 1, 5 and 6. The at least one crimpmember 144 may engage the tension member 150 to secure the tensionmember 150 to the anchor member 130. Alternatively, the anchor member130 may include slots, windows, recesses, apertures (not shown) insetinto the interior diameter of the opening 134 and positioned oppositethe openings 136. The slots (not shown) may be sized and shaped toreceive a pin or engagement member (not shown). The pin (not shown) maybe inserted through the openings 136 to engage the tension member 150and push a portion of the tension member 150 into the opposing slots(not shown) securing the tension member 150 to the anchor member 130.The slots (not shown) may be, for example, slightly offset from theopenings 136 to provide additional securement of the tension member 150to the anchor member 130. The pins (not shown) may also be coupled tothe anchor member 130 by, for example, laser welding to prevent a pinfrom disengaging the anchor member 130 after insertion into a patient.The anchor member 130 may be made of, for example, titanium, stainlesssteel, polymer, and like materials as known by one of ordinary skill inthe art.

Referring now to FIGS. 3-5, the tension member 150 may include a firstend 152 and a second end 154. The first end 152 may be, for example,positioned within the cannulated opening 120 of the head member 110. Thefirst end 152 may be secured to the head member 110 by, for example, aninternal crimping feature or crimp ferrule 128 or, alternatively, pins(not shown) inserted through the at least one opening 118 to engage thetension member 150 and optionally an opposing slot (not shown) asdescribed in greater detail above. The second end 154 may, for example,extend through the anchor member 130 and be positioned between the atleast one crimp member 144. The second end 154 may be secured to theanchor member 130 by, for example, the crimp members 144 or,alternatively, by at least one pin (not shown) inserted through the atleast one opening 136 to engage the tension member 150 and optionally atleast one opposing slot (not shown) as described in greater detailabove. The tension member 150 may be, for example, a braided suture,such as a size #5-#9 braided suture. The tension member 150 may be, forexample, a single cross-section strand of suture or multiple loops.

As shown in FIG. 6, the coupling 160 may include a first engagement endor first mating jaw 164 at a first end and a second engagement end orsecond mating jaw 170 at a second end. The coupling 160 may also includea through hole or cannulated opening 162 extending through the coupling160 along a longitudinal axis of the coupling 160. The first engagementend 164 may include at least one protrusion or tooth 166 and at leastone groove or recess 168, as shown in FIG. 6. For example, in thedepicted embodiment, the first engagement end 164 includes threeprotrusions 166 alternating with three recesses 168. The secondengagement end 170 may include at least one protrusion or tooth 172 andat least one groove or recess 174, as shown in FIG. 6. For example, inthe depicted embodiment, the second engagement end 170 includes threeprotrusions 172 alternating with three recesses 174. The protrusions 172may be spaced, for example, 3 mm apart. The coupling 160 may be made of,for example, a bioresorbable material, such as, PLLA, PGA, PLDA, PL-DLA,copolymers of each, resorbable calcium composites, and like materials asknown by one of ordinary skill in the art.

As shown in FIGS. 1-4 and 6, the anchor member 130 is linked dynamicallyto the head member 110 by a tension member 150 and a coupling 160. Theimplant 100 may be assembled by inserting the engagement end 122 of thehead member 110 with the first engagement end 164 of the coupling 160and the engagement end 138 of the anchor member 130 with the secondengagement end 170 of the coupling 160. The coupling 160 will bepositioned between the head member 110 and the anchor member 130. Withthe cannulated openings 120, 134, 162 of the head member 110, anchormember 130 and coupling 160 aligned, the tension member 150 may beinserted into the cannulated openings 120, 134, 162. The tension member150 may be secured to the head member 110 by securing or tightening thecrimping feature 128 around the tension member 150 and/or inserting pins(not shown) through at least one opening 118 in the head member 110 toengage and secure the tension member 150. The tension member 150 mayalso be secured to the anchor member 130 by securing or tightening thecrimp members 144 around the tension member 150 and/or by inserting pins(not shown) through the at least one opening 136 in the anchor member130 to engage and secure the tension member 150.

Referring now to FIGS. 7-11, a method of inserting the implant 100 isshown. The method may optionally include positioning a plate 184 on abone 182, for example, a fibula. The method may also include driving ak-wire or guide wire 186 through two bones 180, 182, for example, afibula 182 and tibia 180, as shown in FIG. 7. Next, as shown in FIG. 8,a drill 188 may be inserted over the k-wire 186 by aligning a cannulatedopening 190 in the drill 188 with the k-wire 186. The drill 188 may beused to drill an opening 192 through the bones 180, 182. The opening 192may have a diameter, for example, that corresponds to the minor diameterof the anchor member 130. After the opening 192 is drilled, the drill188 and optionally the k-wire 186 may be removed from the bones 180,182, as shown in FIG. 9. Optionally, after removing the drill 188 andprior to removing the k-wire 186, measurements of the depth of theopening 192 may be taken using a cannulated depth gauge (not shown)inserted over the k-wire 186. Once the measurements are taken, thek-wire 186 may then be removed. Alternatively, the k-wire 186 may beremoved from the bones 180, 182 and a standard depth gauge (not shown)may be used to take the measurements. For example, an overall or firstdepth measurement of the opening or drill hole 192, such as ameasurement to the far cortex of the tibia, may be taken using acannulated depth gauge, standard depth gauge or other like instrument.The surgeon may also take a second depth measurement of the portion ofthe opening 192 in the fibula using, for example, a standard depth gaugeor like instrument, to determine the size of the head member 110. Then,an instrument 194 may be used to insert the implant 100 into the opening192 in the bones 180, 182, as shown in FIG. 10. The implant 100 may beinserted to position the anchor member 130 in the tibia 180, the headmember 110 in the fibula 182, and the coupling 160 in a tibiofibularclear space or gap, as shown in FIG. 11. The torsional force applied tothe head member 110 for inserting the implant 100 may be transmitted tothe anchor member 130 through the coupling 160. Next, the instrument 194may be removed from head member 110 of the implant 100, as shown in FIG.11, and the surgical procedure may be completed.

After inserting the implant 100, the coupling 160 will eventually failleaving the head member 110 coupled to the anchor member 130 by only thetension member 150, as shown in FIG. 5. The coupling 160 may fail, forexample, after at least a portion of the coupling 160 is resorbed intothe patient. Failure of the coupling 160 will allow for semi-constrainedmotion between the tibia 180 and fibula 182 via the tension member 150.The flexibility of the tension member 150 may allow for diastatic motionof the implant 100. Thus, the implant 100 allows for the patient'sphysiologic motion to be restored in an anterior-posterior direction, asuperior-inferior direction, as well as allowing for fibular rotation,at the joint based on the strength of the tension member 150 and theresorbable coupling 160.

Referring now to FIGS. 56-61, the implant 200 is illustrated. Theimplant 200 includes a head member or fibula member 210, an anchormember or tibia member 230, a tension member 250, and a coupling 260.The coupling 260 may be positioned between the head member 210 and theanchor member 230 and allow for the anchor member 230 to be secured intothe bones 180, 182 when the head member 210 is rotated. The tensionmember 250 may extend through a center of at least a portion of thealigned head member 210, the coupling 260, and at least a portion of theanchor member 230. The implant 200 may have a length of, for example,approximately 40 mm to 70 mm. In one embodiment, the lengths of the headmember 210 and the coupling 260 may remain constant, while the length ofthe anchor member 230 may be variable to correspond to the varying sizeof a patient's bones 180, 182. Alternatively, in another embodiment, thehead member 210 may, for example, be available in multiple lengths tocorrespond to the varying sizes of patient bones 180, 182 and thelengths of the anchor member 230 and the coupling 260 may remainconstant. In yet another embodiment, both the head member 210 and theanchor member 230 may be available in multiple lengths to allow forselection based on the size of the patient's bones 180, 182 and thecoupling 260 may remain constant. Therefore, the head member 210 mayhave a length of, for example, between approximately 10 mm and 20 mm,the anchor member 230 may have a length of, for example, betweenapproximately 20 mm and 60 mm, and the coupling 260 may have a lengthof, for example, approximately 3 mm.

As shown in at least FIGS. 56-60, the head member 210 includes athreaded shaft member 216 with a head or button 212 at a first end andan engagement end or mating jaw 222 at the second end. The head 212 mayinclude a tool engagement opening 214 positioned opposite the shaftmember 216. The tool engagement opening 214 may have, for example, amulti-lobed shape or other polygonal shape, including a hexagonal shapeor a hexalobular drive feature. The shaft member 216 may include atleast one transverse opening 218 and a through hole or cannulatedopening 220. The cannulated opening 220 may extend through the entirehead member 210 along the longitudinal axis of the head member 210. Theat least one opening 218 may extend perpendicular to the cannulatedopening 220 and may extend from an exterior surface of the head member210 at least into the cannulated opening 220.

The engagement end 222 may include at least one protrusion or tooth 224and at least one groove or recess 226, as shown in FIGS. 56-60. Forexample, the engagement end 222 may include three protrusions 224alternating with three recesses 226. The head member 210 may alsoinclude an internal crimping feature 228, for example, a crimp ferrulepositioned within the through hole 220 near the head 212, as shown inFIGS. 59 and 60. The crimping feature 228 may secure a first end 252 ofthe tension member 250 to the head member 210. Alternatively, the headmember 210 may include slots, windows, recesses, apertures (not shown)inset into the interior diameter of the opening 220 and positionedopposite the openings 218. The slots (not shown) may be sized and shapedto receive a pin or engagement member (not shown). The pin (not shown)may be inserted through the openings 218 to engage the tension member250 and push a portion of the tension member 250 into the opposing slots(not shown) securing the tension member 250 to the head member 210. Theslots (not shown) may be, for example, slightly offset from the openings218 to provide additional securement of the tension member 250 to thehead member 210. The pins (not shown) may also be coupled to the headmember 210 by, for example, laser welding to prevent a pin fromdisengaging the head member 210 after insertion into a patient. The headmember 210 may be made of, for example, titanium, stainless steel,polymer, or another like material as would be known by one of ordinaryskill in the art. Although not shown, the head member 210 may, forexample, also optionally be threaded on at least a portion of theexterior surface between the head 212 and the engagement end 222.

With continued reference to FIGS. 56-61, the anchor member 230 mayinclude a threaded shaft 232 with an engagement end or mating jaw 240 ata first end and an insertion end 236 at a second end. The insertion end236 may also include at least one cutting element 238, for example, atleast one cutting flute, as shown in at least FIGS. 56-58. The at leastone cutting element may be, for example, four cutting flutes. It is alsocontemplated that the cutting flutes at the insertion end may be used asa removal feature if a medial approach is used to remove at least theanchor member 230. The threaded shaft 232 may be, for example, threadedalong the entire length of the shaft or only along a portion of theshaft. The threaded shaft 232 may also include a through hole orcannulated opening 234 extending from the first end to the second endalong the longitudinal axis of the anchor member 230. The engagement endor mating jaw 240 may include at least one protrusion or tooth 242 andat least one groove or recess 244, as shown in FIGS. 56-60. For example,the engagement end 240 may include three protrusions 242 alternatingwith three recesses 244.

The threaded shaft 232 may also include at least one transverse opening246 extending from an exterior surface of the threaded shaft 232 intothe through hole 234. The anchor member 230 may include slots, windows,recesses, apertures 248 inset into the interior diameter of the opening234 or extending from an exterior surface of the threaded shaft 232 intothe through hole 234. The slots 248 may be positioned, for example,opposite the openings 246. The slots 248 may be sized and shaped toreceive a pin or engagement member 249. The pin 249 may be insertedthrough the openings 246 to engage the tension member 250 and push aportion of the tension member 250 into the opposing slots 248 securingthe tension member 250 to the anchor member 230, as shown in FIGS. 59and 60. Although not shown, the slots 248 may be, for example, slightlyoffset from the openings 246 to provide additional securement of thetension member 250 to the anchor member 230. The pins 249 may also becoupled to the anchor member 230 by, for example, laser welding toprevent a pin from disengaging the anchor member 230 after insertioninto a patient. The anchor member 230 may be made of, for example,titanium, stainless steel, polymer, and like materials as known by oneof ordinary skill in the art.

Referring now to FIGS. 59 and 60, the tension member 250 may include afirst end 252 and a second end 254. The first end 252 may be, forexample, positioned within the cannulated opening 220 of the head member210. The first end 252 may be secured to the head member 210 by, forexample, an internal crimp ferrule 228 or, alternatively, pins (notshown) inserted through the at least one opening 218 to engage thetension member 250 and optionally an opposing slot (not shown) asdescribed in greater detail above. The second end 254 may, for example,extend through a portion of the anchor member 230. The second end 254may be secured to the anchor member 230 by, for example, at least onepin 249 inserted through the at least one opening 246 to engage thetension member 250 and at least one opposing slot 248 as described ingreater detail above. The tension member 250 may be, for example, abraided suture, such as a size #5-#9 braided suture. The tension member250 may be, for example, a single cross-section strand of suture ormultiple loops.

As shown in FIGS. 56-60, the coupling 260 may include a first engagementend or first mating jaw 264 at a first end and a second engagement endor second mating jaw 270 at a second end. The coupling 260 may alsoinclude a through hole or cannulated opening 262 extending through thecoupling 260 along a longitudinal axis of the coupling 260. The firstengagement end 264 may include at least one protrusion or tooth 266 andat least one groove or recess 268, as shown in FIG. 56-59. For example,the first engagement end 264 may include three protrusions 266alternating with three recesses 268. The second engagement end 270 mayinclude at least one protrusion or tooth 272 and at least one groove orrecess 274, as shown in FIGS. 56-59. For example, the second engagementend 270 may include three protrusions 272 alternating with threerecesses 274. The protrusions 272 may be spaced, for example, 3 mmapart. The coupling 260 may be made of, for example, a bioresorbablematerial, such as, PLLA, PGA, PLDA, PL-DLA, copolymers of each,resorbable calcium composites, and like materials as known by one ofordinary skill in the art.

As shown in FIGS. 56-61, the anchor member 230 is linked dynamically tothe head member 210 by a tension member 250 and a coupling 260. Theimplant 200 may be assembled by inserting the engagement end 222 of thehead member 210 with the first engagement end 264 of the coupling 260and the engagement end 240 of the anchor member 230 with the secondengagement end 270 of the coupling 260. The coupling 260 will bepositioned between the head member 210 and the anchor member 230. Withthe cannulated openings 220, 234, 262 of the head member 210, anchormember 230 and coupling 260, respectively, aligned, the tension member250 may be inserted into the cannulated openings 220, 234, 262. Thetension member 250 may be secured to the head member 210 by securing ortightening the crimp ferrule 228 around the tension member 250 and/orinserting pins (not shown) through at least one opening 218 in the headmember 210 to engage and secure the tension member 250. The tensionmember 250 may also be secured to the anchor member 230 by insertingpins 249 through the at least one opening 246 in the anchor member 230to engage and secure the tension member 250 and/or by securing ortightening crimp members (not shown) around the tension member 250 atthe second end.

A method of inserting the implant 200 may optionally include positioninga plate 184 on a bone 182, for example, a fibula. The method may alsoinclude driving a k-wire or guide wire 186 through two bones 180, 182,for example, a fibula 182 and tibia 180, as shown in FIG. 7. Next, asshown in FIG. 8, a drill 188 may be inserted over the k-wire 186 byaligning a cannulated opening 190 in the drill 188 with the k-wire 186.The drill 188 may be used to drill an opening 192 through the bones 180,182. The opening 192 may have a diameter, for example, that correspondsto the minor diameter of the anchor member 130. After the opening 192 isdrilled, the drill 188 and optionally the k-wire 186 may be removed fromthe bones 180, 182, as shown in FIG. 9. Optionally, after removing thedrill 188 and prior to removing the k-wire 186, measurements of thedepth of the opening 192 may be taken using a cannulated depth gauge(not shown) inserted over the k-wire 186. Once the measurements aretaken, the k-wire 186 may then be removed. Alternatively, the k-wire 186may be removed from the bones 180, 182 and a standard depth gauge (notshown) may be used to take the measurements. For example, an overall orfirst depth measurement of the opening or drill hole 192, such as ameasurement to the far cortex of the tibia, may be taken using acannulated depth gauge, standard depth gauge or other like instrument.The surgeon may also take a second depth measurement of the portion ofthe opening 192 in the fibula using, for example, a standard depth gaugeor like instrument, to determine the size of the head member 210. Then,an instrument may be used to insert the implant 200 into the opening 192in the bones 180, 182. The implant 200 may be inserted to position theanchor member 230 in the tibia 180, the head member 210 in the fibula182, and the coupling 260 in a tibiofibular clear space or gap. Thetorsional force applied to the head member 210 for inserting the implant200 may be transmitted to the anchor member 230 through the coupling260. Next, the instrument may be removed from head member 210 of theimplant 200 and the surgical procedure may be completed.

After inserting the implant 200, the coupling 260 will eventually failleaving the head member 210 coupled to the anchor member 230 by only thetension member 250. The coupling 260 may fail, for example, after atleast a portion of the coupling 260 is resorbed into the patient.Failure of the coupling 260 will allow for semi-constrained motionbetween the tibia 180 and fibula 182 via the tension member 250. Theflexibility of the tension member 250 may allow for diastatic motion ofthe implant 200. Thus, the implant 200 allows for the patient'sphysiologic motion to be restored in an anterior-posterior direction, asuperior-inferior direction, as well as allowing for fibular rotation,at the joint based on the strength of the tension member 250 and theresorbable coupling 260.

Referring now to FIGS. 12-16, another implant 300 is shown. The implant300 includes the head member 110 and the anchor member 330. The implant300 also includes the coupling 160 positioned between the head member110 and the anchor member 330 for insertion of the implant 300. The headmember 110 and drive coupling 160 are described above in greater detailwith respect to implant 100 and will not be described again here forbrevity sake. Finally, the implant 300 includes a tension member 310positioned in a cannulated opening extending through the implant 300, asshown in FIGS. 14-16.

The tension member 310, as shown in FIGS. 14-16, includes a first end312 and a second end, crimp ferrule, or stop member 314. The stop member314 may be, for example, integral, monolithic or removable from thetension member 310. The diameter of the first end 312 may be, forexample, smaller than the diameter of the second end 314. The tensionmember 310 may be, for example, a stranded cerclage cable or similarconstruct. The tension member 310 may also be made of, for example,titanium, stainless steel, polymers, polyester or UHMWPE suture,resorbable suture, co-braids thereof, or a like material, as known byone of ordinary skill in the art. The first end 312 of the tensionmember 310 may be, for example, positioned within the cannulated opening120 of the head member 110. The first end 312 may be secured to the headmember 110 by a crimping feature 128 and/or by pins (not shown). If pins(not shown) are used, the head member 110 may include slots, windows,recesses, apertures (not shown) inset into the interior diameter of theopening 120 and positioned opposite the openings 118. The slots (notshown) may be sized and shaped to receive a pin or engagement member(not shown). The pin (not shown) may be inserted through the openings118 to engage the tension member 310 and push a portion of the tensionmember 310 into the opposing slots (not shown) securing the tensionmember 310 to the head member 110. The slots (not shown) may be, forexample, slightly offset from the openings 118 to provide additionalsecurement of the tension member 310 to the head member 110. The pins(not shown) may also be coupled to the head member 110 by, for example,laser welding to prevent a pin from disengaging the head member 110after insertion into a patient.

Referring now to FIGS. 12-16, the anchor member or tibia member 330 isshown. The anchor member 330 may include a threaded shaft 332 with acannulated opening or through hole 334 extending through the entireanchor member 330 along a longitudinal axis. The threaded shaft 332 maybe, for example, threaded along the entire length of the shaft or onlyalong a portion of the shaft. The anchor member 330 may also include anengagement end or mating jaw 336 at a first end and a cutting end orteeth 342 at a second end. The engagement end 336 may include at leastone protrusion or tooth 338 and at least one groove or recess 340, asshown in FIGS. 12-15. For example, the engagement end 336 may includethree protrusions 338 alternating with three recesses 340. The secondend of the anchor member 330 may also include a bore 344 extending intothe anchor member 330 from the second end and engaging the cannulatedopening 334. The bore 344 may be, for example, larger than thecannulated opening 334. The bore 344 and cannulated opening 334 mayhave, for example, a round or circular cross-section and the diameter ofthe bore 344 may be larger than the diameter of the cannulated opening334. The size and shape of the bore 344 may correspond to the size andshape of the second end 314 of the tension member 310 to allow thesecond end 314 to translate within the bore 344 of the anchor member330. Although not shown, it is also contemplated that the second end orcutting end 342 of the anchor member 330 may include at least onecutting element, for example, at least one cutting flute, such as thecutting flutes on the insertion end 536, as shown in FIGS. 24-32. The atleast one cutting element may be, for example, four cutting flutes. Itis also contemplated that the cutting flutes at the insertion end may beused as a removal feature if a medial approach is used to remove atleast the anchor member 330.

With continued reference to FIGS. 14-16, the first end 312 of thetension member 310 may be inserted through the second end 314 of theanchor member 130 and through the cannulated opening 334. Next, thefirst end 312 of the tension member 310 may be inserted through thethrough hole 162 in the coupling 160 and into the head member 110through the second end until the first end 312 reaches a position beforethe tool engagement opening 114. The tension member 310 may then besecured to the head member 110 using the crimping feature 128 or,alternatively, by inserting at least one pin (not shown) through theopenings 118 in the head member 110. Once assembled, the tension member310 is rigidly coupled to the head member 110 and once at least aportion of the bioresorbable coupling 160 resorbs into the patient, theanchor member 330 may translate along the tension member 310. The anchormember 330 may translate between contacting the engagement end 122 ofthe head member 110 at a first end and contacting the second end or stopmember 314 of the tension member 310 at the second end. In a fullyextended position, the stop member 314 may be fully inserted into thebore 344 of the anchor member 330, as shown in FIGS. 14-16. In aninsertion position, the engagement end 436 of the anchor member 430engages a first end of the coupling 160 and the engagement end 122 ofthe head member 110 engages a second end of the coupling 160 to allowfor the torsional force of the insertion instrument to be translated tothe anchor member 330.

Referring now to FIGS. 7-9 and 16, a method of inserting the implant 300is shown. The method may include forming the opening 192, as shown inFIGS. 7-9 and described in greater detail above with reference toimplant 100, which will not be described again here for brevity sake.Next, as shown in FIG. 16, an instrument 194, for example, a driverinstrument may be used to insert the implant 300 into the opening 192 inthe bones 180, 182. The torsional force applied to the head member 110for inserting the implant 300 may be transmitted to the anchor member330 through the coupling 160. Next, the instrument 194 may be removedfrom head member 110 of the implant 300 and the surgical procedure maybe completed. After inserting the implant 300, the coupling 160 willeventually fail leaving the head member 110 coupled to the anchor member330 by only the tension member 310. The coupling 160 may fail, forexample, after at least a portion of the coupling 160 is resorbed intothe patient. Failure of the coupling 160 allows for semi-constrainedmotion between the tibia 180 and fibula 182 via the tension member 310.The flexibility of the tension member 310 may allow for diastatic motionof the implant 300. Thus, the implant 300 allows for the patient'sphysiologic motion to be restored in an anterior-posterior direction,superior-inferior direction, as well as allowing for fibular rotation,at the joint based on the strength of the tension member 310 and theresorbable coupling 160.

Referring now to FIGS. 17-23, another implant 400 is shown. The implant400 includes a head member 110, an anchor member 430, and a tensionmember 410 that couples the head member 110 and the anchor member 430,as shown in FIGS. 19-23. The head member 110 is described above ingreater detail with respect to implant 100 and will not be describedagain here for brevity sake. The tension member 410 may extend through acenter of at least a portion of the aligned head member 110 and at leasta portion of the anchor member 430. The implant 400 may have a lengthof, for example, approximately 40 mm to 70 mm. In one embodiment, thelength of the head member 110 may remain constant, while the length ofthe anchor member 430 may be variable to correspond to the varying sizeof a patient's bones 180, 182. Alternatively, in another embodiment, thehead member 110 may, for example, be available in multiple lengths tocorrespond to the varying sizes of the patient's bones 180, 182 and thelength of the anchor member 430 may remain constant. In yet anotherembodiment, both the head member 110 and the anchor member 430 may beavailable in multiple lengths to allow for selection based on the sizeof the patient's bones 180, 182. The tension member 410 may provide agap of, for example, 3 mm when the head member 110 and anchor member 430are fully extended.

As shown in FIGS. 19-23, the tension member 410 may include a first end412 and a second end, crimp ferrule, or stop member 414. The diameter ofthe first end 412 may be, for example smaller than the diameter of thesecond end 414. The tension member 410 may be a stranded cerclage cableor similar construct. The tension member 410 may also be made of, forexample, titanium, stainless steel, polymers, polyester or UHMWPEsuture, resorbable suture, co-braids thereof, or a like material asknown by one of ordinary skill in the art.

Referring now to FIGS. 17-23, the anchor member or tibia member 430 isshown. The anchor member 430 may include a threaded shaft 432 with acannulated opening or through hole 434 extending through the entireanchor member 430 along a longitudinal axis. The threaded shaft 432 maybe, for example, threaded along the entire length of the shaft or onlyalong a portion of the shaft. The anchor member 430 may also include anengagement end or mating jaw 436 at a first end and a cutting end orteeth 442 at a second end. The engagement end 436 may include at leastone protrusion or tooth 438 and at least one groove or recess 440, asshown in FIGS. 17-20. For example, as shown in FIG. 17, the engagementend 436 includes three protrusions 438 alternating with three recesses440. The second end of the anchor member 430 may also include a bore 444extending into the anchor member 430 from the second end and engagingthe cannulated opening 434. The bore 444 may be, for example, largerthan the cannulated opening 434. The bore 444 and cannulated opening 434may have, for example, a round or circular cross-section and thediameter of the bore 444 may be larger than the diameter of thecannulated opening 434. The size and shape of the bore 444 maycorrespond to the size and shape of the second end 414 of the tensionmember 410 to allow the second end 414 to translate within the bore 444of the anchor member 430. Although not shown, it is also contemplatedthat the second end or cutting end 442 of the anchor member 430 mayinclude at least one cutting element, for example, at least one cuttingflute, such as the cutting flutes on the insertion end 536, as shown inFIGS. 24-32. The at least one cutting element may be, for example, fourcutting flutes. It is also contemplated that the cutting flutes at theinsertion end may be used as a removal feature if a medial approach isused to remove at least the anchor member 430.

The implant 400 may be assembled, for example, by inserting the firstend 412 of the tension member 410 through the second end of the anchormember 430 and through the cannulated opening 434. Next, the first end412 of the tension member 410 may be inserted into the head member 110through the second end until the first end 412 reaches a position beforethe tool engagement opening 114. The tension member 410 may then besecured to the head member 110 by inserting at least one pin (not shown)through the openings 118 in the head member 110. Once assembled, thetension member 410 is rigidly coupled to the head member 110 and theanchor member 430 may translate along the tension member 410. The anchormember 430 may translate between contacting the engagement end 122 ofthe head member 110 at a first end and contacting the second end or stopmember 414 of the tension member 410 at the second end. In a fullyextended position, the stop member 414 may be fully inserted into thebore 444 of the anchor member 430, as shown in FIGS. 19, 20, 22 and 23.In an insertion position, as shown in FIG. 21, the engagement end 436 ofthe anchor member 430 engages the engagement end 122 of the head member110 to allow for the torsional force of the insertion instrument to betranslated to the anchor member 430.

Referring now to FIGS. 7-9 and 21-23, a method of using the implant 400is shown. The method may include forming the opening 192, as shown inFIGS. 7-9 and described in greater detail above with reference toimplant 100, which will not be described again here for brevity sake.Next, as shown in FIG. 21, an instrument or screw driver 450 may be usedto insert the implant 400 into the opening 192 in the bones 180, 182.Thus instrument or screw driver 450 may include a through hole orcannulated opening 452 to receive a disengagement suture 454 duringinsertion of the implant 100. The torsional force applied to the headmember 110 for inserting the implant 400 may be transmitted to theanchor member 430 through the engagement of the mating jaw 122 of thehead member 110 with the mating jaw 436 of the anchor member 430. Next,the instrument 450 may be removed from the head member 110 of theimplant 400 by sliding the instrument 450 off of the disengagementsuture 454, as shown in FIG. 22. After the instrument 450 is removed,the first end 456 of the disengagement suture 454 may be pulled. As thefirst end 456 is pulled, the second end 458 of the disengagement suture454, which is coupled to the implant 400, is also pulled and disengagesthe mating jaw 122 of the head member 110 from the mating jaw 436 of theanchor member 430. Once the disengagement suture is pulled, the anchormember 430 may translate to seat the stop member 414 into the bore 444to fully extend or expand the implant 400 and provide the tibiofibularclear space or gap d between the tibia 180 and fibula 182, as shown inFIG. 22. When the implant 400 is in an expanded position, theflexibility of the tension member 410 may allow for restoration ofphysiologic motion of the joint as the tension member 410 flexes. Next,the disengagement suture 454 may be cut, as shown in FIG. 23, and thesurgical procedure may be completed.

Referring now to FIGS. 24-36, another implant 500 is shown. The implant500 includes a head member 510, an anchor member 530, a tension member550, and an elastic member 560 (see FIGS. 27-33). The tension member 550couples the head member 510 to the anchor member 530. The tension member550 may create, for example, a dynamic link between the head member 510and anchor member 530. The elastic member 560 allows for motion betweenthe head member 510 and the anchor member 530. In addition, the elasticmember 560 provides support for the tension member 550. The implant 500may have a length of, for example, approximately 40 mm to 70 mm. Thetension member 550 may form a gap between the head member 510 and theanchor member 530 with the length of the gap being, for example,approximately 8 mm. The head member 510 and gap created by the tensionmember 550 may, for example, remain constant and the length of theanchor member 530 may, for example, vary based on the anatomy of thepatient. Alternatively, the length of the head member 510 may also varybased on the anatomy of the patient, while the length of the anchormember 530 and gap remain constant. In a further embodiment, the lengthof the head member 510 and the anchor member 530 may vary based on thepatient's anatomy and the gap may remain constant.

As shown in at least FIGS. 24-32, the head member or fibula member 510includes a head 512 and a shaft member 516 extending away from a secondend of the head 512. The head 512 may also include a tool engagementopening 514 positioned on a first end opposite the shaft member 516, asshown in FIGS. 25, 30, 32. In addition, the head member 510 may includea through hole or cannulated opening 518 extending from the toolengagement opening 514 at the first end to the second end of the headmember 510 along the longitudinal axis. The second end may also includean engagement end 520 for coupling to the tension member 550, as shownin FIGS. 24-28. The engagement end 520 may include a capture member orswag feature 522 positioned at the second end of the head member 510.The capture member 522 may include a plurality of suture holes orcapture holes 524 positioned around the exterior surface of the headmember 510, as shown in FIGS. 24-26 and 29-32. The plurality of sutureholes 524 may align with recesses 526 in the shaft member 516 adjacentto the capture member 522. The plurality of suture holes 524 andrecesses 526 may be positioned to receive a portion of a suture 552 ofthe tension member 550, as shown in FIGS. 24-26 and 28. Although anynumber of suture holes 524 and recesses 526 are contemplated, in oneembodiment, the head member 510 may include, for example, six sutureholes 524 aligned with six recesses 526. The head member 510 may be madeof, for example, titanium, stainless steel or a like material as knownby one of ordinary skill in the art. Although not shown, at least aportion of the shaft member 516 of the head member 510 may be, forexample, threaded.

With continued reference to FIGS. 24-32, the anchor member or tibiamember 530 is shown. The anchor member 530 may include a threaded shaft532 with an insertion end 536 at one end and an engagement end 538 atthe other end. The anchor member 530 may also include a hole or opening534 extending from the distal end toward the proximal end or engagementend 538, as shown in FIGS. 24 and 27-29. The engagement end 538 mayinclude grooves or recesses 540 positioned around the exterior surfaceof the anchor member 530. The grooves 540 may be aligned with the sutureholes 524 of the head member 510. Protrusions 542 may be formed betweenthe grooves 540 of the anchor member 530. The grooves 540 may alsoinclude at least one opening, slot or through hole 544 extending fromthe grooves 540 into the opening 534. As shown in FIGS. 27 and 28, theanchor member 530 may also include a bumper opening 546 positioned inthe proximal end of the opening 534. The bumper opening 546 may be sizedand shaped or configured to receive the elastic member 560, as shown inFIGS. 27 and 28. Further, the anchor member 530 may include an anchorelement or anchor instrument opening 548 positioned at the proximal endof the anchor member 530, as shown in FIGS. 25, 27, 28, 30 and 32. Theinsertion end 536 may also include at least one cutting element, forexample, at least one cutting flute, as shown in FIGS. 24-32. The atleast one cutting element at the insertion end 536 may be, for example,four cutting flutes. It is also contemplated that the cutting flutes atthe insertion end 536 may be used as a removal feature if a medialapproach is used to remove at least the anchor member 530. The anchormember 530 may be made of, for example, titanium, stainless steel,polymer, or a like material as known by one of ordinary skill in theart.

The tension member 550, as shown in FIGS. 24-32, may include at leastone suture 552. The sutures 552 may be, for example, braided sutures ormonofilament to provide additional flexibility in diastasis. The suture552 may have a first end 554, a second end 556 and a middle portion 558positioned between the first end 554 and the second end 556, as shown inFIGS. 31 and 32. The first end 554 and second end 556 of the tensionmember 550 may be received within the holes 524 of the head member 510,as shown in FIG. 28. For example, the first end 554 of a suture 552 maybe received within a hole 524 that is positioned directly opposite thehole 524 which receives the second end 556 of the same suture 552. Inaddition, the middle portion 558 may be positioned within the grooves540 of the anchor member 530 and extend through the openings 544 in theanchor member 530, as best shown in FIG. 28. The middle portion 558 may,for example, extend between two openings 544 that are positionedopposite each other. The tension member 550 may include, for example,three sutures 552 forming six suture lengths, as shown in FIGS. 29-32.The implant 500 may include, for example, one to four sutures 552forming two to eight suture lengths, alternatively, the implant 500 mayinclude two to eight single sutures lengths. The sutures 552 may be, forexample, braided suture, size #0. The sutures 552 may be made of, forexample, polyester, UHMWPE, absorbable material, and the like as knownby one of ordinary skill in the art.

The elastic member, compliant bumper or bumper 560, as shown in FIGS.27-32, may include a first end and a second end. The elastic member 560may also include a through hole 562 extending from the first end to thesecond end along a longitudinal axis of the elastic member 560. Theelastic member 560 may be made of, for example, an extrudedthermoplastic urethane (TPU) with a durometer of, for example, 75-95Shore A. The elastic member 560 may have an outer diameter of, forexample, approximately 1.5 mm. The inner diameter of the elastic member560 may vary based on the desired ligament stiffness. The elastic member560 may have a length of, for example, approximately 3 mm. To obtain thedesired elastic deformation the length, inner diameter and outerdiameter of the elastic member 560 may be adjusted.

The implant 500 may be assembled by inserting an elastic member 560 intothe bumper opening 546 in the anchor member 530. Next, the middleportion 558 of the at least one suture 552 may be inserted through theat least one opening 544 in the anchor member 530 distal to the elasticmember 560, as shown in FIGS. 27 and 28. Then, the first and second ends554, 556 of the sutures 552 may be inserted into the suture holes 524 inthe head member 510 and secured to provide the desired gap between theanchor member 530 and the head member 510. To secure the sutures 552 tothe head member 510, the exterior structure forming the suture holes 524may be deformed to capture or lock the suture ends 554, 556 to the headmember 510. After the sutures 552 are secured in the holes 524 of thehead member 510 any excess suture material may be removed or cut to asize that fits within the suture recesses 526. Then, the implant 500 isready for insertion into a patient. The assembled implant 500 allows fordiastatic motion by the sutures 552 compressing the elastic member 560when the head member 510 in the fibula 182 is pulled away from the tibia180. The elastic deformation of the elastic member 560 allows for thecompression and resulting motion off the implant 500. The elastic member560 may have a stiffness that is, for example, equal to that of aphysiologically intact syndesmosis, such as 50-200 N/mm.

An insertion instrument or inserter 570 is shown in FIGS. 33-34. Theinsertion instrument 570 includes a first shaft member 572 coupled to ahandle or driver instrument (not shown) and a second shaft member 574extending away from the first shaft member 572. The first shaft member572 may have a larger diameter than the second shaft member 574. Thesecond shaft member 574 may have a first end and a second end. The firstend of the second shaft member 574 is coupled to the first shaft member572. The first end of the second shaft member 574 may include a proximalfeature 576. The proximal feature 576 may be, for example, a custom hexdrive feature, as shown in FIGS. 33 and 34. The proximal feature 576 maybe sized and shaped or configured to engage the tool engagement opening514 of the head member 510, as shown in FIG. 35. The second end of thesecond shaft member 574 may include a distal feature 578. The distalfeature 578 may be, for example, a modified T7 drive feature, as shownin FIGS. 33 and 34. The distal feature 578 may be sized and shaped orconfigured to engage the tibia anchor element 548 of the anchor member530, as shown in FIG. 35. The inserter 570 may also include acaptivation sleeve 580 that couples to or clips on the head 512 of thehead member 510. The captivation sleeve 580 maintains the axial spacingof the implant 500 during insertion. In addition, the captivation sleeve580 self-releases from the implant 500 upon the bottoming out ofcaptivation sleeve 580 when the head member 510 engages the fibula 182.The captivation sleeve 580 also provides support to the head 512 of thehead member 510 during insertion or implantation to minimize the stresson the tension member 550 until the implant 500 is fully seated. Theinserter 570 also allows for the fully assembled implant 500 to beinserted and for all of the components of the implant 500 to rotatetogether.

Referring now to FIGS. 7-9 and 35-36, a method of inserting the implant500 is shown. The method may include forming the opening 192, as shownin FIGS. 7-9 and described in greater detail above with reference toimplant 100, which will not be described again here for brevity sake.Next, as shown in FIG. 35, an insertion instrument 570 may be used toinsert the implant 500 into the opening 192 in the bones 180, 182. Theinstrument 570 engages the anchor member 530 and head member 510 toprovide uniform torsional force to the anchor member 530 and the headmember 510. Once the implant 500 is fully inserted, i.e., the inserter570 bottoms out causing detachment of the inserter 570 from the implant500, as shown in FIG. 36. The inserter 570 can then be removed. Finally,the surgical procedure may be completed.

Another implant 600 is shown in FIGS. 37-45. The implant 600 includes ahead member 510, an anchor member 610, and a tension member 640 couplingthe head member 510 to the anchor member 610. The head member 510 isdescribed above in greater detail with respect to implant 500 and willnot be described again here for brevity sake.

As shown in FIGS. 37-43, the anchor member 610 includes a threaded shaft612 with a first end and a second end. The anchor member 610 mayoptionally include a hole 614 extending into the threaded shaft 612 fromthe second end or insertion end 616, as shown in FIGS. 39 and 40. Thefirst end of the anchor member 610 includes an engagement end 618, asshown in FIGS. 37-43. The engagement end 618 includes grooves orrecesses 620, 624, 628 separate by protrusions 632. The distal end ofeach groove 620, 624, 628 may include an opening or through hole 622,626, 630. The grooves 620, 624, 628 may have different lengths. Forexample, the first groove 620 may have a first length, the second groove624 may have a second length and the third groove 628 may have a thirdlength. The first length may be shorter than the second and thirdlengths and the third length may be longer than the first and secondlengths. Each opening 622, 626, 630 may, for example, connect twocorresponding grooves 620, 624, 628 positioned opposite of each otheraround the circumference of the engagement end 618. The grooves 620,624, 628 and openings 622, 626, 630 may be sized and shaped orconfigured to receive a suture 642, 650, 658, as shown in FIGS. 37-40and described in greater detail below. The engagement end 618 of theanchor member 610 may also include an element or tibia anchor element634 inset into the end of the anchor member 610, as shown in FIGS. 37,39-41 and 43. The element 634 may be sized and shaped or configured toreceive an insertion instrument, such as instrument 570, as described ingreater detail above with reference to implant 500, which will not bedescribed again here for brevity sake. The insertion end 616 may includeat least one cutting element, for example, at least one cutting flute,as shown in FIGS. 37-43. The at least one cutting element at theinsertion end 616 may be, for example, four cutting flutes. It is alsocontemplated that the cutting flutes at the insertion end 616 may beused as a removal feature if a medial approach is used to remove theanchor member 610. The anchor member 610 may be made of, for example,titanium, stainless steel, polymer, or a like material as known by oneof ordinary skill in the art.

With continued reference to FIGS. 37-45, the tension member 640 mayinclude at least one suture 642, 650, 658. The sutures 642, 650, 658 maybe, for example, braided or monofilament sutures to provide additionalflexibility in diastasis. The suture 642, 650, 658 may have a first end644, 652, 660, a second end 646, 654, 662 and a middle portion 648, 656,664 positioned between the first end 644, 652, 660 and the second end646, 654, 662, as shown in FIG. 43. The first end 644, 652, 660 andsecond end 646, 654, 662 of the tension member 640 may be receivedwithin the holes 524 of the head member 510, as shown in FIGS. 37-40.For example, the first end 644, 652, 660 of a suture 642, 650, 658 maybe received within a hole 524 that is positioned directly opposite thehole 524 which receives the second end 646, 654, 662 of the same suture642, 650, 658. In addition, the middle portion 648, 656, 664 may bepositioned within the grooves 620, 624, 628 of the anchor member 610 andextend through the openings 622, 626, 630 in the anchor member 610, asbest shown in FIG. 40. The middle portion 648, 656, 664 may, forexample, extend through the opening 622, 626, 630. The tension member640 may include, for example, three sutures 642, 650, 658 forming sixsuture lengths, as shown in FIGS. 41-43. The implant 600 may include,for example, one to four sutures 642, 650, 658 forming two to eightsuture lengths, alternatively, the implant 600 may include two to eightsingle sutures lengths. The sutures 642, 650, 658 may be, for example,braided suture, size #0. The sutures 642, 650, 658 may be made of, forexample, polyester, UHMWPE, resorbable material, and the like as knownby one of ordinary skill in the art.

The implant 600 may be assembled by inserting the sutures 642, 650, 658through the openings 622, 626, 630 in the anchor member 610, as shown inFIGS. 37 and 40. Specifically, the first suture 642 may be inserted, forexample, through the opening 622 in the anchor member 610 and the middleportion 648 may extend through the opening 622, as shown in FIG. 40.Similarly, the second suture 650 may be inserted, for example, throughthe opening 626 in the anchor member 610 and the middle portion 656 mayextend through the opening 626. In addition, the third suture 658 may beinserted, for example, through the opening 630 in the anchor member 610and the middle portion 664 may extend through the opening 630. Further,the first suture 642 may be aligned with the grooves 620 in the anchormember 610 and the first and second ends 644, 646 may be inserted intothe suture holes 524 in the head member 510. The first and second ends644, 646 may also be secured in the suture holes 524 to provide thedesired gap or space between the anchor member 610 and the head member510. Similarly, the second suture 650 may be aligned with the grooves624 in the anchor member 610 and the first and second ends 652, 654inserted into the suture holes 524 in the head member 510. The first andsecond ends 652, 654 may also be secured in the suture holes 524 toprovide the desired gap or space between the anchor member 610 and thehead member 510. In addition, the third suture 658 may be aligned withthe grooves 628 and the first and second ends 660, 662 may be insertedinto the suture holes 524 in the head member 510. The first and secondends 660, 662 may also be secured in the suture holes 524 to provide thedesired gap or space between the anchor member 610 and the head member510. The first and second ends 644, 646, 652, 654, 660, 662 of eachsuture 642, 650, 658 may be inserted into suture holes 524 positionedopposite each other. To secure the sutures 642, 650, 658 to the headmember 510, the exterior structure forming the suture holes 524 may bedeformed to capture or lock the suture ends 644, 646, 652, 654, 660, 662to the head member 510. After the sutures 642, 650, 658 are secured inthe holes 524 of the head member 510 any excess suture material may beremoved or cut to a size that fits within the suture recesses 526. Theimplant 600 may then be inserted into a patient.

Referring now to FIGS. 7-9 and 44-45, a method of inserting the implant600 is shown. The method may include forming the opening 192, as shownin FIGS. 7-9 and described in greater detail above with reference toimplant 100, which will not be described again here for brevity sake.Next, as shown in FIG. 44, an insertion instrument 570 may be used toinsert the implant 600 into the opening 192 in the bones 180, 182. Theinstrument 570 engages the anchor member 610 and head member 510 toprovide uniform torsional force to the anchor member 610 and head member510 during insertion. Once the implant 600 is fully inserted, i.e., theinserter 570 may bottom out detaching the inserter 570 from the implant600. The inserter may then be removed, as shown in FIG. 45. Finally, thesurgical procedure may be completed.

Referring now to FIGS. 46-52, another implant 700 is shown. The implant700 includes a head member 510, an anchor member 610, a tension member640 and a resorbable spacer 710. The head member 510, anchor member 610,and tension member 640 are described above in greater detail withrespect to implants 500 and 660 and will not be described again here forbrevity sake. The spacer 710 is positioned between the head member 510and the anchor member 610 and constrained by the tension members 640.The implant 700 acts as a solid or one piece construct or screwconstraining motion until the spacer 710 is resorbed. Once the spacer710 is resorbed, the implant 700 will have semi-constrained motion asallowed by the tension member 640 positioned between the head member 510and anchor member 610. The semi-constrained motion approximates thephysiological motion of an intact syndesmosis. Therefore, the spacer 710provides a more constrained joint initially to protect the ligamentsduring early healing, and once the spacer 710 resorbs, a more naturalrange of motion is allowed to promote faster healing of the injury. Forexample, the spacer 710 may take 6-8 weeks to be resorbed and this timemay be adjusted based on the type and thickness of the resorbablematerial used.

As shown in FIGS. 48-52, the resorbable spacer 710 may include a firstend 712, a second end 714 opposite the first end 712, and a plurality ofgrooves or channels 716 extending between the first end 712 and thesecond end 714. The channels 716 may be positioned to align with thegrooves 620, 624, 628 of the anchor member 610 and the suture holes 524and recesses 526 of the head member 510. The channels 716 may also be,for example, sized and shaped or configured to receive the sutures 642,650, 658 as they extend between the head member 510 and the anchormember 610, as shown in FIGS. 46 and 47. The resorbable spacer 710 mayalso include a protrusion or extension (not shown) extending away fromthe second end 714 of the spacer 710 to engage the element 634 of theanchor member 610. In addition, the spacer 710 may have, for example, asolid or cannulated cross-section. The spacer 710 may be made of, forexample, PLLA, PGA, PLDA, PL-DLA, copolymers of each, resorbable calciumcomposites, or any like material as known by one of ordinary skill inthe art.

The implant 700 may be assembled by inserting the sutures 642, 650, 658through the openings 622, 626, 630 in the anchor member 610, as shown inFIGS. 46-49. Specifically, the first suture 642 may be inserted, forexample, through the opening 622 in the anchor member 610 and the middleportion 648 may extend through the opening 622, as shown in FIG. 49.Similarly, the second suture 650 may be inserted, for example, throughthe opening 626 in the anchor member 610 and the middle portion 656 mayextend through the opening 626. In addition, the third suture 658 may beinserted, for example, through the opening 630 in the anchor member 610and the middle portion 664 may extend through the opening 630. Thespacer 710 may be positioned between the anchor member 610 and the headmember 510, aligning the channels 716 with the grooves 620, 624, 628 ofthe anchor member 610 and the suture holes 524 and recesses 526 of thehead member 510. The first suture 642 may be aligned with the grooves620 in the anchor member 610 and the first and second ends 644, 646 maybe inserted into the suture holes 524 in the head member 510. The firstand second ends 644, 646 may also be secured in the suture holes 524 sothat the anchor member 610 and the head member 510 contact the spacer710. Similarly, the second suture 650 may be aligned with the grooves624 in the anchor member 610 and the first and second ends 652, 654inserted into the suture holes 524 in the head member 510. The first andsecond ends 652, 654 may also be secured in the suture holes 524 so thatthe anchor member 610 and the head member 510 contact the spacer 710. Inaddition, the third suture 658 may be aligned with the grooves 628 andthe first and second ends 660, 662 may be inserted into the suture holes524 in the head member 510. The first and second ends 660, 662 may alsobe secured in the suture holes 524 so that the anchor member 610 and thehead member 510 contact the spacer 710. The first and second ends 644,646, 652, 654, 660, 662 of each suture 642, 650, 658 may be insertedinto suture holes 524 positioned opposite each other. To secure thesutures 642, 650, 658 to the head member 510, the exterior structureforming the suture holes 524 may be deformed to capture or lock thesuture ends 644, 646, 652, 654, 660, 662 to the head member 510. Afterthe sutures 642, 650, 658 are secured in the holes 524 of the headmember 510 any excess suture material may be removed or cut to a sizethat fits within the suture recesses 526. The implant 700 may then beinserted into a patient.

Referring now to FIGS. 7-9 and 52, a method of inserting the implant 700is shown. The method may include forming the opening 192, as shown inFIGS. 7-9 and described in greater detail above with reference toimplant 100, which will not be described again here for brevity sake.Next, as shown in FIG. 52, an insertion instrument 570 may be used toinsert the implant 700 into the opening 192 in the bones 180, 182. Theinstrument 570 engages the head member 510 and passes through the spacer710 to engage the anchor member 610 to provide uniform torsional forceto the entire implant 700 during insertion. Alternatively, if the headmember 510 and/or spacer 710 are not cannulated, the instrument 570 mayengage the tool engagement opening 514 of the head member 510 and thespacer 710 may engage the instrument opening 548 of the anchor member610 to provide the torsional force to the anchor member 610. Once theimplant 700 is fully inserted, i.e., the inserter 570 bottoms outcausing the inserter 570 to detach from the implant 700. The implant 700may then be removed. Finally, the surgical procedure may be completed.

Referring now to FIG. 53, another tension member 800 is shown. Thetension member 800 may be used with, for example, implants 500, 600,700. The tension member 800 may include at least one suture 802, 804,806. For example, the tension member 800 may include a first suture 802,a second suture 804 and a third suture 806. The lengths of the sutures802, 804, 806 may vary initially. The shortest suture 802, 804, 806 willdefine the gap or space between the head member 510 and anchor member530, 610 and the other two sutures 802, 804, 806 will each have apredefined laxity. Once an implant 500, 600, 700 having the tensionmember 800 is implanted into a patient, the shortest suture 802, 804,806 will define the amount of motion that is possible between the tibia180 and fibula 182. Over time, the shortest suture 802, 804, 806 willbreak and the next shortest suture 802, 804, 806 will then define theamount of motion permitted between the tibia 180 and fibula 182. Thesutures 802, 804, 806 will continue to break over time allowing for therelative distance between the head member 510 and anchor member 530, 610to incrementally increase. As the relative distance between the headmember 510 and anchor member 530, 610 incrementally increases, theamount of physiologic motion between the bones 180, 182 also increasesover time. The number and strength of the sutures 802, 804, 806 may beselected, such that once all of the sutures 802, 804, 806 have broken,the syndesmosis should be theoretically healed.

Referring now to FIGS. 54 and 55, another alternative tension member 850is shown. The tension member 850 may be used with, for example, implants500, 600. The tension member 850 may include at least one suture 852,854, 856. For example, the tension member 850 includes a first suture852, a second suture 854 and a third suture 856. The sutures 802, 804,806 may be woven such that tension pulls them towards the axis of theimplant 500, 600 and allows for diastatic motion between the tibia 180and fibula 182.

An exemplary embodiment of another implant according to the presentdisclosures is shown in FIGS. 62-87 and generally indicated with thereference numeral 900. Some aspects, elements and/or functions ofexemplary implant 900 are the same or similar in structure and/orfunction, at least in part, to the exemplary implants 100, 200, 300,400, 500, 600 and/or 700 described above and shown in FIGS. 1-62, andtherefore like reference numerals preceded by the numeral “9” are usedto indicate like components, aspects, configurations, functions orprocesses, and the description above directed thereto (and thealternative embodiments thereof) equally applies to the implant 900.

As shown in FIGS. 62-87, the implant 900 includes a head member orfibula member 910, a head post 928, an anchor member or tibia member930, a tip post 944, a tension member 950, a biocompatible coupling 960and at least one resilient and/or elastic tensioning member 951. Thecoupling 960 is positioned between the head member 910 and the anchormember 930 and allows for the anchor member 930 to be secured into thebones 980, 982 when the head member 910 is torqued or rotated. Thetension member 950 may extend at least partially through a cannulatedopening, through hole or passageway extending through the implant 900along the longitudinal axis thereof, such as at least partially throughthe head post 928 (which is positioned within an opening of the headmember 910, the tip post 944 (which is positioned within an opening ofthe anchor member 930) and the coupling 960.

In one embodiment, the axial lengths of the head member 910 and thecoupling 960 may remain constant, while the length of the anchor member930 may be variable to correspond to the varying size of a patient'sbones. Alternatively, in another embodiment, the head member 910 may,for example, be available in multiple lengths to correspond to thevarying sizes of patient bones and the lengths of the anchor member 930and the coupling 960 may remain constant. In yet another embodiment,both the head member 910 and the anchor member 930 may be available inmultiple lengths to allow for selection based on the size of thepatient's bones and the coupling 960 may remain constant.

As shown in at least FIGS. 62-73, 76, 77, 82 and 86, the head member 910may comprise a shaft portion 916 with a head portion 912 at a first endand an engagement end or projection 922 at a second end. The shaftportion 916 may be, for example, threaded along a portion of the shaft,such as a portion extending from or proximate to the head portion 912.The head member 910 also includes an axially/longitudinally extendingthrough hole, cannulated opening or passageway 920 that extends betweenthe first and second ends, as shown in FIGS. 62-73, 76, 77, 82 and 86.The head portion 912 includes a tool engagement opening 914 having anirregular or non-circular cross-sectional shape so that acorrespondingly shaped tool can mate therewith and apply a torque to theimplant 900 to rotate the implant 900 about its axis. The engagementopening 914 may include or be a portion of the through hole 920.

As shown in at least FIGS. 68-73, 76 and 77, the engagement end 922 ofthe head member 910 may be irregular or non-circular in cross-section,and a first end of the coupling 960 may include a corresponding ormating aperture 964, so that the head member 910 is able to transfertorque to the coupling 960 when the engagement end 922 is seated orpositioned within the aperture 964. In some embodiments, the engagementend 922 of the head member 910 may include at least one protrusion orlobe 924 and at least one groove or recess 926, as shown in FIGS. 68-73,76 and 77. For example, in the depicted embodiment, the engagement end922 includes four lobes 924 alternating with four recesses 926.

The anchor member 930 may comprise a shaft portion 932 with anengagement end or protrusion 938 at a first end and a crimp portion 933at a second end, as shown in FIGS. 62-71 74, 75, 78, 83 and 84. Thethreaded shaft 932 may be, for example, threaded along a portion of theshaft, such as a portion extending from or proximate to the engagementend 938. An end portion of the threads of the anchor member 930proximate to the second end may include at least one cutting element,for example, at least one flute (such as a cutting flute). The crimpportion 933 may be a non-threaded portion of the anchor member 930 thatextends from the threaded portion to the second end of the anchor member930. The anchor member 930 also includes an axially/longitudinallyextending through hole, cannulated opening or passageway 934 thatextends between the first and second ends, as shown in FIGS. 62-71 74,75, 78, 83 and 84.

As shown in at least FIGS. 68-70 and 74-77, the engagement end 938 ofthe anchor member 930 may be irregular or non-circular in cross-section,and a second end of the coupling 960 may include a corresponding ormating aperture 970, so that the coupling 960 is able to transfer torqueto the anchor member 930 when the engagement end 938 is seated orpositioned within the aperture 970. In some embodiments, the engagementend 938 of the anchor member 930 may include at least one protrusion orlobe 924 and at least one groove or recess 926, as shown in FIGS. 68-70and 74-77. For example, in the depicted embodiment, the engagement end938 includes four lobes 924 alternating with four recesses 926.

The aperture 964 at the first end of the coupling 960 and the aperture970 at the second end of the coupling 960 may be in communication via anaxially/longitudinally extending through hole, cannulated opening orpassageway 971 that extends through the coupling 960 between the firstand second ends thereof. The apertures 964, 970 at the first and secondends of the coupling 960 may thereby include or be a portion of thethrough hole 920.

The coupling 960 may couple the head member 910 and the anchor member930 together such that the implant 900, as a whole, can be inserted orimplanted (via rotation or torque applied by a tool via the engagementopening 914 of the head portion 912) into first and second bones like ascrew. The implant 900 may be implanted such that the coupling 960 ispositioned, at least partially, between the joint or space between thefirst and second bones. The coupling 960 may be made of a bioresorbablematerial so that after implantation, the implant 900 provides a firstperiod of substantially rigid fixation of the first and second bones,and then after the coupling 960 is absorbed/resorbed, a second phase ofsemi-constrained and/or dynamic motion between the first and secondbones (provided by the tension member 950, as described later). Forexample, the implant 900 may be inserted into a tibia and fibula after asyndesmotic reduction to only temporarily fix the tibia and fibula. Insome such embodiments, the implant 900 may be inserted into a tibia andfibula following a repair of an ankle fracture, such as a fibulafracture. The coupling 960 may be formed of any bioresorbable material,such as for example one or more bioabsorbable polymers (PGA, PLA, PLLA,PLDA, PL-DLA, PLGA (e.g., PLGA 91:15), PDS and copolymers thereof), oneor more bioabsorbable metal (e.g., a magnesium alloy),ultra-high-molecular-weight polyethylene (UHMWPE), or a combinationthereof (or any other like bioresorbable material as known by one ofordinary skill in the art).

As shown in FIGS. 68-78 and 80-87, the tension member 950 may be anelongated structure or member that extends from or proximate to (and isaffixed to) the second end of the anchor member 930 and at leastproximate to (and is affixed to) the head portion 912 of the head member910. The tension member 950 may be of any configuration or structure.The tension member 950 may be, for example, a stranded cerclage cable orsimilar construct. The tension member 950 may also be made of, forexample, titanium, stainless steel, polymers, polyester, polypropyleneor UHMWPE suture, co-braids thereof, or a like material, as known by oneof ordinary skill in the art. The tension member 950 may be, forexample, a suture (e.g., a braided suture), such as a singlecross-section strand of suture or multiple loops of suture. For example,the tension member 950 may be a UHMWPE and polypropylene co-braidsuture. The tension member 950 may or may not be elasticallyaxially/longitudinally stretchable or deformable.

In the exemplary illustrated embodiment of the implant 900, the tensionmember 950 comprises a bifurcated suture loop. As shown in FIGS. 68-78and 80-87, the tension member 950 may include a medial bifurcatedportion extending between the first and second end portions 952, 954.The first and second end portions 952, 954 include non-bifurcated,closed or solid portions that define ends of the medial bifurcatedportion. As shown in FIGS. 68-78 and 80-87, the medial bifurcatedportion of the tension member 950 may include first and second openingsor portions 956, 958 adjacent to the non-bifurcated or solid portions ofthe first and second closed end portions 952, 954. As explained furtherbelow, the first and second openings 956, 958 of the tension member 950are configured to accommodate or accept pins extending therethrough sothat the tension member 950 can be pulled into tension (or apply tensileforces that act to pull the head member 910 and the anchor member 930together along the longitudinal axis).

The first end portion 952 of the tension member 950 may be coupled tothe head member 910 within the cannulated opening 920 thereof via thehead post 928, as shown in FIGS. 62, 63, 82 and 85-87. The head post 928may be contained or positioned within the cannulated opening 920 of thehead member 910. Specifically, the cannulated opening 952 of the headmember 910 is configured to allow the head post 928 to axially slide ortranslate therein. As shown in FIGS. 62, 63, 82 and 85-87, thecannulated opening 952 of the head member 910 includes an enlargedportion positioned proximate to the first end/head portion 912 that issized and shaped to contain the head post 928 and allow the head post928 to axially travel therein. The cannulated opening 952 of the headmember 910 also includes a reduced or narrow portion positionedproximate to the second end/engagement end 922 of the head member 910that is sized and shaped to allow the tension member 950 to passtherethrough, but that prevents the head post 928 from passingtherethrough.

As shown in FIGS. 68-73, 82 and 85-87, the head post 928 includes anaxially/longitudinally extending through hole, cannulated opening orpassageway 929 extending therethrough that is configured to allow thefirst end portion 952 of the tension member 950 to pass therethrough.The head post 928 also includes at least one laterally/radiallyextending pin aperture or hole 918 that extends from the exterior of thehead post 928 to the cannulated opening 929. The first end portion 952of the tension member 910 can be inserted or passed through thecannulated opening 929 of the head post 928 such that the first opening956 is aligned with the pin aperture 918. With the first opening 956being aligned with the pin aperture 918, a head pin 919 can be pressedinto/through the pin aperture 918 and into/through the first opening 956to fix the first end portion 952 of the tension member 910 to the headpost 928, as shown in FIGS. 68-73, 82 and 85-87. In some embodiments,the head pin 919 may initially be partially disposed or pre-assembledwithin a portion of the pin aperture 918 prior to passing the tensionmember 950 through the cannulated opening 929.

The second end portion 952 of the tension member 950 may be coupled tothe anchor member 930 within the cannulated opening 934 thereof via thetip post 944, as shown in FIGS. 78, 80, 81 and 83-855. The tip post 944may be contained or positioned within the cannulated opening 934 of theanchor member 930 (e.g., the cannulated opening 934 of the crimp portion933 and the threaded shaft portion 932). Specifically, the cannulatedopening 934 of the anchor member 934 (e.g., the cannulated opening 934of the crimp portion 933 and the threaded shaft portion 932) isconfigured to allow the tip post 944 to axially slide or translatetherein in a neutral, natural or undeformed or un-crimped state, asshown in FIGS. 78, 83 and 84. As explained further below, the crimpportion 933 of the anchor member 930 may be inwardly deformed or crimpedsuch that the cannulated opening 934 thereof is narrowed or partiallycollapsed to fixed or trap the tip post 944 within a particular orselected axial positioned or location within the cannulated opening 934along the anchor member 930.

As shown in FIGS. 65, 68-71, 74, 75, 78-81, 83 and 84, the tip post 944includes an axially/longitudinally extending through hole, cannulatedopening or passageway 939 extending therethrough that is configured toallow the second end portion 954 of the tension member 950 to passtherethrough. The tip post 944 also includes at least onelaterally/radially extending pin aperture or hole 936 positionedproximate to a second end of the tip post 944. The pin aperture 936extends from the exterior of the tip post 944 to the cannulated opening939. The first end portion 952 of the tension member 910 can be insertedor passed through the cannulated opening 939 of the tip post 944 suchthat the second opening 958 is aligned with the pin aperture 936. Withthe second opening 958 being aligned with the pin aperture 936, a tippin 935 can be pressed into/through the pin aperture 936 andinto/through the second opening 958 to fix the second end portion 954 ofthe tension member 910 to the tip post 944, as shown in FIGS. 78, 80,81, 83 and 84. In some embodiments, the tip pin 935 may initially bepartially disposed or pre-assembled within a portion of the pin aperture936 prior to passing the tension member 950 through the cannulatedopening 939.

The tip post 944 also includes a hook slot 937 (e.g., a “J”, “L” or “T”shaped slot) extending from a second end thereof. The hook slot 937 maydefine a slot or passageway that is open to the second end of the tippost 944. The hook slot 937 is configured to allow a member (e.g., asuture, tool or other member or device) (not shown) to extendtherein/therethrough to engage the tip post 944 and apply an axialtensioning force to the tip post 944, as shown in FIGS. 65, 68-71, 74,75, 78-81, 83 and 84. When the tip post 944 is positioned within thecannulated opening 934 of the anchor member 930, the member (not shown),may extend through the cannulated opening 934 and engage the hook slot937. The tensioning force applied to the tip post 944 via the hook slot937 may act in a direction extending from the head portion 912 to thefree end or tip of the anchor member 930.

As shown in FIGS. 65, 68-71, 74 75 78-81, 83 and 84, the tip post 944includes a crimp recess or groove 945 extending into the outer surfaceof the tip post 944. The crimp recess 945 may extend circumferentiallyabout the tip post 944. The crimp recess 945 may be positioned betweenthe hook slot 937 and the pin aperture 936. The crimp recess 945 isconfigured such that when the tip post 944 is positioned within thecannulated opening 934 of the anchor member 912, a space or gap isformed between the crimp recess 945 and the inner surface of the anchormember 912 forming the cannulated opening 934, as shown in FIGS. 78, 83and 84. In this way, as described above, the crimp portion 933 of theanchor member 912 may be crimped (i.e., deformed inwardly) such that theside wall of the crimp portion 933 extends into the cannulated opening934 and the crimp recess 945 (i.e., the cannulated opening 934 isnarrowed or partially collapsed into the crimp recess 945) to fix ortrap the tip post 944 within a particular or selected axial/longitudinalposition or location within the cannulated opening 934 along the anchormember 930.

As shown in FIGS. 68-83, 82 and 85-87, the at least one resilient and/orelastic tensioning member 951 may also be positioned within the enlargedportion of the cannulated opening 929 of the head member 910. The atleast one resilient member 951 may be positioned axially/longitudinallybetween the head post 928 and the narrow portion of the cannulatedopening 929. The at least one resilient member 951 may also extend aboutthe tension member 950. For example, the at least one resilient member951 may extend circumferentially about the bifurcated portion of thetension member 950. The at least one resilient member 951 may therebyinclude a through hole that accepts the tension member 950.

The at least one resilient member 951, the narrow portion of thecannulated opening 929 and/or the head post 928 can be configured (e.g.,sized and shaped) such that the at least one resilient member 951 istrapped or contained between the head post 928 and the narrow portion ofthe cannulated opening 929, as shown in FIG. 82. In this way, when thetension member 950 is tensioned via the tip post 944, the at least oneresilient member 951 may be elastically compressed between the end ofthe enlarged portion of the cannulated opening 929 of the head member910. The at least one resilient member 951 may thereby apply acompressive force that pulls the anchor member 930 and the head member910 together after the coupling 960 is resorbed, and/or allows a limiteddegree of relative axial translation or movement between the anchormember 930 and the head member 910. In some alternative embodiments, theat least one resilient member 951 may not be positioned within thecannulated opening 929 of the head member 910. In some embodiments, theat least one resilient member 951 may be contained or embedded within abioresorbable material. In some embodiments, the at least one resilientmember 951 may be formed of a bioresorbable material.

The at least one resilient member 951 may be formed of any elasticallydeformable member or material. For example, the at least one resilientmember 951 may be one or more springs (e.g., disc or coil spring) orelastically compressible disc or tube, or a combination thereof. Forexample, the at least one resilient member 951 may comprise anelastically compressible disc (e.g., elastomeric, polymer, polyurethaneor polyethylene disc), tube (e.g., a polyurethane tube) or coil spring.In some embodiments, the at least one resilient member 951 comprises aplurality of disc springs, and may include at least one elastomeric(e.g., polyurethane), polymer (e.g., polyethylene) and/or resorbabledisc between at least one pair of adjacent disc springs. However, the atleast one resilient member 951 may be of any other configuration suchthat the at least one resilient member 951 is elastically deformable totension the tension member 950 so that it applies a preloadedcompressive force (via elastic deformation of the at least one resilientmember 951) that pulls the anchor member 930 and the head member 910together (before and/or after the coupling 960 is resorbed), and/orallows a limited degree of relative axial translation or movementbetween the anchor member 930 and the head member 910 (before and/orafter the coupling 960 is resorbed).

As shown in FIGS. 68-83, 82 and 85-87, in the exemplary illustrativeembodiment the at least one resilient member 951 is comprises of aplurality of disc springs 953 (also known as coned-disc springs, conicalspring washers, cupped spring washers, Belleville springs and Bellevillewashers) which can be axially/longitudinally loaded either statically ordynamically. The disc springs 953 include a central through hole thatallows the tension members 950 to extend therethrough. The disc springs953 include or define a frusto-conical shape that provides a spring orelastic deformation characteristic thereof.

The frusto-conical shape of the disc springs 953 also allows for abimodal configuration of the at least one resilient member 951 such thatthe at least one resilient member 951 includes relatively stiffer andrelatively less stiff sections or portions. Specifically, thefrusto-conical shape of the disc springs 951 allows some disc springs951 to be stacked or arranged next to each other in the sameaxial/longitudinal direction or orientation and some other disc springs951 to be stacked or arranged next to each other in the opposingaxial/longitudinal directions or orientations. The disc springs 951 thatare stacked or arranged next to each other in the sameaxial/longitudinal direction or orientation provide a relatively stifferportion or configuration of the at least one resilient member 951 ascompared to that formed by the disc springs 951 that are arranged in anopposing or oppositely orientated arrangement. By including at leastsome disc springs 951 arranged in the same direction and at least somedisc springs 951 arranged in an opposing direction, the at least oneresilient member 951 can provide both an assembly tension that maintainsthe components of the implant 900 together during/after implantation andprior to absorption of the coupling 960 (via the oppositely orientateddisc springs 951) and an in-situ tension (via the aligned disc springs951) after implantation (before and/or after absorption of the coupling960) to resist anatomical forces, such as syndesmotic forces. Forexample, if the implant is implanted into a fibula and a tibia with thecoupling 960 at least partially positioned within the lateral gutterthereof, the in-situ tension provided at least partially by the aligneddisc springs 951 allows or provides for a recoverable diastatic motionof the fibula relative to the tibia, acting to release, absorb and/ordissipate pressure spikes in the lateral gutter, for example. In someembodiments, the oppositely orientated disc springs 951 may beelastically deformed such that the assembly tension maintains thecomponents of the implant 900 mated together, and the oppositelyorientated disc springs 951 may not be elastically deformed (or onlypartially elastically deformed) so as to provide the in-situ tension inresponse to the recoverable diastatic motion and pressure spikes.

The implant 900 may be assembled (i.e., the anchor member 930 and thehead member 910 dynamically linked by the tension member 950, at leastone resilient member 951 and the coupling 960) by positioning the secondend portion 954 of the tension member 950 within the cannulated opening936 of the tip post 944 such that the bifurcated portion of the tensionmember 950 is aligned with the pin aperture 936 of the tip post 944 (andpotentially the tip pin 935 if pre-assembled with the tip post 944). Thesecond opening 958 of the tension member 950 may be aligned with the pinaperture 936 of the tip post 944 and the tip pin 935 may be pressed orotherwise translated through the pin aperture 936 such that the tip pin935 extends through the second opening 958 to couple the tension member950 and the tip post 944 (i.e., to capture the tension member 950 in thetip post 944), as shown in FIGS. 80 and 81.

The pre-assembled tension member 950 and tip post 944 may be assembledwith the anchor member 930, the coupling 960, the head member 910, theat least one resilient member 951 and the head post 928. For example,the first end portion 952 of the tension member 950 may be inserted intoand through the cannulated opening 934 of the anchor member 930 via theopening at the end of the crimp portion 933, into and through thecannulated opening 971 of the coupling 960, into and through thecannulated opening 920 of the head member 910, into and through thethrough hole of the at least one resilient member 951 (if the throughhole is provided), and into and through the cannulated opening 929 ofthe head post 928. The tension member 950 may be positioned within thecannulated openings of the implant 900 such that the tip post 944 isalso positioned or translated into the cannulated opening 934 of theanchor member 930.

The first end portion 952 of the tension member 950 may be positionedwithin the cannulated opening 929 of the head post 928 such that thebifurcated portion of the tension member 950 is aligned with the pinaperture 918 of the head post 928 (and potentially the head pin 919 ifpre-assembled with the head post 928). The first opening 956 of thetension member 950 may be aligned with the pin aperture 918 of the headpost 928 and the head pin 919 may be pressed or otherwise translatedthrough the pin aperture 918 such that the head pin 919 extends throughthe first opening 956 to couple the tension member 950 and the head post928 (i.e., to capture the tension member 950 in the head post 928), asshown in FIG. 82.

With the tension member 950 and the head post 928 couple, the tensionmember 950 may be tensioned via the hook slot 937 of the tip post 944 toaxially seat, engage or assemble the components of the implant 900 andapply the assembly tension. For example, a member or tool (e.g., asuture) (not shown) may be inserted into the cannulated opening 934 ofthe anchor member 930 and engaged with the hook slot 937 of the tip post944. The tip post 944 and tension member 950 may initially be positioneddistal to the free end or tip of the anchor member 930 (formed by thecrimp portion 933) within the cannulated opening 934, as shown in FIG.78. The member or tool may be tensioned to “pull” the tip post 944 viathe hook slot 937 axially/longitudinally through the cannulated opening934 of the anchor member 930 proximate to the free end or tip of theanchor member 930 within the cannulated opening 934, as shown in FIG.84. The tension member 950 may thereby also be axially/longitudinallytranslated through the cannulated opening 934 of the anchor member 930,which causes the head post 928 to seat within the cannulated opening 920of the head member 910 and act against the at least one elastic member951 to trap the at least one elastic member 951 between the narrowportion of the cannulated opening 920 and the head post 928.Axial/longitudinal translation of the tension member 950 through thecannulated opening 934 of the anchor member 930 may also cause headmember 910 to act against the at least one elastic member 951 and fullyseat the engagement projection 922 of the head member 910 within theengagement aperture 964 of the coupling 960 and the engagementprojection 938 of the anchor member 930 within the engagement aperture970 of the coupling 960 (if not already fully seated therein), as shownin FIGS. 62-67, 77, 82 and 86.

Further axial/longitudinal transition of the tip post 944 and the secondend 954 of the tension member 950 through the cannulated opening 934 ofthe anchor member 930 toward the free end or tip of the anchor member930 (via “pulling” or tensioning via the hook slot 937) causes the headpost 928 to compress the at least one resilient member 951 (between thehead post 928 and the end of the enlarged portion of the cannulatedopening 920 of the head member 910) to elastically deform the at leastone resilient member 951. The at least one resilient member 951 maythereby apply the assembly tension force to the anchor member 930 andthe head member 910 via the tension member 950 acting to pull (or push)the anchor member 930 and the head member 910 together. As describedabove, the at least one resilient member 951 may have portions ofdiffering stiffnesses, and the at least one resilient member 951 mayonly be partially elastically compressed or deformed so that arelatively less stiff portion is deformed to provide the assemblytension force but a relatively stiffer portion is not deformed (or onlypartially deformed) so that in situ forces can be dissipated or absorbedby deformation of the stiffer portion. To fix or maintain the assemblytension force, the position of the tip post 944 proximate to the freeend or tip of the anchor member 930 within the cannulated opening 934may be fixed or maintained via crimping or inwardly deforming the crimpportion 933 of the anchor member 930 into the crimp recess 945 of thetip post 944 (not shown).

As described above with respect to implant 100-700, after implanting orinserting the implant 900 into first and second bones with the coupling960 at least partially positioned in a joint or space therebetween, thecoupling 960 will eventually fail leaving the head member 910 coupled tothe anchor member 930 by only the tension member 950. The coupling 960may fail, for example, after at least a portion of the coupling 960 isresorbed into the patient. Failure of the coupling 960 will allow forsemi-constrained motion between the first and second bones via thetension member 950 and the at least one resilient member 951. Theflexibility of the at least one resilient member 951 (and potentiallythe tension member 950) may allow for diastatic motion of the implant900. Thus, the implant 900 allows for the patient's physiologic motionto be restored, as well as allowing for diastatic motion and/or pressurespikes, for example.

An exemplary embodiment of another implant according to the presentdisclosures is shown in FIGS. 88-91 and generally indicated with thereference numeral 1000. Some aspects, elements and/or functions ofexemplary implant 1000 are the same or similar in structure and/orfunction, at least in part, to the exemplary implants 100, 200, 300,400, 500, 600, 700 and/or 900 described above and shown in FIGS. 1-87,and therefore like reference numerals preceded by the numeral “10” areused to indicate like components, aspects, configurations, functions orprocesses, and the description above directed thereto (and thealternative embodiments thereof) equally applies to the implant 1000.

As shown in FIGS. 88-91, the implant 1000 is substantially similar toimplant 900. As shown in FIGS. 88-91, the implant 1000 is differs fromthe implant 900 with respect to the configuration of the at least oneresilient member 1051. The at least one resilient member 1051 comprisesa bumper positioned within the cannulation 1020 of the head member 1010,as shown in FIGS. 88-91. Specifically, as shown in FIGS. 88-91, thebumper 1051 is positioned within the enlarged portion of the cannulation1020 of the head member 1010 between the head post 1028 and the narrowportion of the of the cannulation 1020 of the head member 1010. As shownin FIGS. 88-91, the bumper 1051 may be formed as a tube with athrough-aperture or cannulation 1073 extending therethrough. The tensionmember 1050 (e.g., the first end portion 1052 thereof) may thereby passthrough the cannulation 1073 of the bumper 1051.

The elastic bumper 1051 may be formed of any resilient and/or elasticmaterial. In some embodiments, the bumper 1051 may be formed of one ormore urethanes, such as one or more thermoplastic urethanes. Forexample, the bumper 1051 may be elastic and/or formed of thermoplasticurethane (TPU), polycarbonate urethane (PCU) or a combination thereof.

An exemplary embodiment of another head member of/for an implantaccording to the present disclosures is shown in FIGS. 92 and 93 andgenerally indicated with the reference numeral 1110. Some aspects,elements and/or functions of exemplary head member 1110 are the same orsimilar in structure and/or function, at least in part, to the exemplaryhead members 110, 210, 310, 410, 510, 610, 710, 910 and/or 1010described above and shown in FIGS. 1-87, and therefore like referencenumerals preceded by the numeral “11” are used to indicate likecomponents, aspects, configurations, functions or processes, and thedescription above directed thereto (and the alternative embodimentsthereof) equally applies to the implant 1000. Similarly, the head member1110 may be utilized as the head member of any of exemplary implants100, 200, 300, 400, 500, 600, 700 and/or 900 described above and shownin FIGS. 1-87.

As shown in FIGS. 92 and 93, a portion of the through hole, cannulatedopening or passageway 1120 of the head member 1110 may include aninternally-threaded portion 1121. For example, the internally-threadedportion 1121 may be proximate to and/or extend from the engagementopening 1114. The internally-threaded portion 1121 may be threadablyengaged with a head post or member (not shown) that is coupled to afirst end portion of a tension member (not shown). For example, the headpost 928 of FIGS. 62-87 or the head post 1028 of FIGS. 88-91 may beexternally threaded and threadably engaged with the internally-threadedportion 1121.

A head post or member threadably engaged with the internally-threadedportion 1121 of the cannulation 1120 of the head member 1110 may includea non-circular engagement opening or aperture having an irregular ornon-circular cross-sectional shape so that a correspondingly shaped toolcan mate therewith and apply a torque to the head post or member torotate the head post or member. The head post or member may thereby belongitudinally/axially translated within the head post or member alongthe internally-threaded portion 1121 of the cannulation 1120 of the headmember 1110. In this way, the head post or member and theinternally-threaded portion 1121 of the cannulation 1120 of the headmember 1110 may be utilized to tension the tension member when a secondend portion of the tension member is fixed or coupled to another portionof the implant. It is noted that the tension member that is coupled oraffixed to the tension member may be twisted or untwisted as the headpost or member is rotated within the internally-threaded portion 1121 ofthe cannulation 1120 of the head member 1110.

As may be recognized by those of ordinary skill in the art based on theteachings herein, numerous changes and modifications may be made to theabove-described and other embodiments of the present disclosure withoutdeparting from the scope of the disclosure. The head member, anchormember, tension member, coupling, and other components of the implantand/or system as disclosed in the specification, including theaccompanying abstract and drawings, may be replaced by alternativecomponent(s) or feature(s), such as those disclosed in anotherembodiment, which serve the same, equivalent or similar purpose as knownby those skilled in the art to achieve the same, equivalent or similarresults by such alternative component(s) or feature(s) to provide asimilar function for the intended purpose. In addition, the implants andsystems may include more or fewer components or features than theembodiments as described and illustrated herein. For example, thecomponents and features of FIGS. 1-11, FIGS. 12-16, FIGS. 17-23, FIGS.24-32, 35 and 36, FIGS. 37-45, FIGS. 46-52, FIG. 53, FIG. 54, FIG. 55,FIGS. 56-61 and FIGS. 62-87 may all be used interchangeably and inalternative combinations as would be modified or altered by one of skillin the art. Accordingly, this detailed description of thecurrently-preferred embodiments is to be taken in an illustrative, asopposed to limiting of the disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” (andany form of comprise, such as “comprises” and “comprising”), “have” (andany form of have, such as “has”, and “having”), “include” (and any formof include, such as “includes” and “including”), and “contain” (and anyform of contain, such as “contains” and “containing”) are open-endedlinking verbs. As a result, a method or device that “comprises,” “has,”“includes,” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of a device that “comprises,” “has,” “includes,” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Furthermore, adevice or structure that is configured in a certain way is configured inat least that way, but may also be configured in ways that are notlisted.

The disclosure has been described with reference to the preferredembodiments. It will be understood that the architectural andoperational embodiments described herein are exemplary of a plurality ofpossible arrangements to provide the same general features,characteristics, and general system operation. Modifications andalterations will occur to others upon a reading and understanding of thepreceding detailed description. It is intended that the disclosure beconstrued as including all such modifications and alterations.

What is claimed is:
 1. An implant, comprising: a head member,comprising: at least one engagement protrusion; an anchor member,comprising: at least one engagement protrusion; and a threaded shaft,wherein the threaded shaft comprises: at least one transverse opening;and at least one slot opposite and aligned with the at least onetransverse opening; a tension member coupling the head member to theanchor member, wherein the head member and the anchor member include acannulation that receives the tension member therein, wherein the atleast one transverse opening of the anchor member extends from anexterior surface of the threaded shaft into the cannulation, and whereinthe at least one slot is inset in the cannulation; a coupling memberpositioned between and coupling the head member and the anchor member,wherein the coupling member comprises: at least one recess disposed at afirst engagement end that receives the at least one engagementprotrusion of the head member; at least one recess disposed at a secondengagement end that receives the at least one engagement protrusion ofthe anchor member; and the cannulation that receives the tension membertherethrough; and at least one pin, wherein the pin is sized to beinserted into the at least one transverse opening and at least one slot,wherein the at least one pin pressingly engages the tension member intothe at least one slot to secure the tension member to the anchor member.2. The implant of claim 1, wherein the head member pressingly engagesthe first engagement end of the coupling member.
 3. The implant of claim2, wherein the cannulation extends through the head member, the couplingmember and at least a portion of the anchor member, wherein thecannulation extends parallel to a longitudinal axis of the implant. 4.The implant of claim 3, wherein the head member comprises a head portionand a shaft portion extending from the head portion, the head portiondefining a free end of the implant.
 5. The implant of claim 4, whereinthe head portion includes a non-circular tool engagement opening and theshaft portion includes external threads.
 6. The implant of claim 5,wherein the tool engagement opening is in communication with thecannulation of the head member.
 7. The implant of claim 6, wherein thehead member further includes a first opening, wherein the first openingextends perpendicular to the cannulation.
 8. The implant of claim 1,wherein the tension member is a suture.
 9. The implant of claim 8,wherein the suture includes a loop.
 10. The implant of claim 9, whereinthe suture is braided.
 11. The implant of claim 8, wherein the sutureincludes multiple loops.
 12. The implant of claim 1, wherein the tensionmember is made of a bioresorbable material.
 13. The implant of claim 1,wherein the coupling member is made of a bioresorbable material.
 14. Theimplant of claim 1, wherein the head member, the coupling member and theanchor member have a length, wherein the length of the anchor member isgreater than the length of the coupling member and/or the head member.15. A system, comprising: an implant comprising: a head member,comprising: a first engagement protrusion; an anchor member, comprising:a second engagement protrusion; and a threaded shaft, wherein thethreaded shaft comprises: at least one transverse opening; and at leastone slot opposite and aligned with the at least one transverse opening;a tension member coupling the head member to the anchor member, whereinthe head member and the anchor member include a cannulation thatreceives the tension member therein and therethrough, wherein the atleast one transverse opening of the anchor member extends from anexterior surface of the threaded shaft into the cannulation, and whereinthe at least one slot is inset in the cannulation; a coupling memberpositioned between and coupling the head member and the anchor member,wherein the coupling member comprises: a first engagement aperture thatreceives the first engagement protrusion of the head member; and asecond engagement aperture that receives the second engagementprotrusion of the anchor member; and at least one pin, wherein the pinis sized to be inserted into the at least one transverse opening and atleast one slot, wherein the at least one pin pressingly engages thetension member into the at least one slot to secure the tension memberto the anchor member; and an insertion instrument for coupling to theimplant.
 16. The system of claim 15, wherein the head member, thecoupling member and the anchor member have a length, wherein the systemcomprises a plurality of head members having varying lengths, aplurality of anchor members having varying lengths and a coupling memberof a constant length.
 17. The system of claim 15, wherein the headmember, the coupling member and the anchor member have a length, whereinthe system comprises a plurality of head members having varying lengths,wherein the lengths of the plurality of head members are variableranging from 10 millimeters to 30 millimeters and the anchor member andcoupling member each have a constant length.